Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

SONGER® SPINAL CABLE SYSTEM

Model 186.201S · Pioneer Surgical Technology, Inc. · DI 00846468023607

JDQ — Cerclage, Fixation · Class II · 21 CFR 888.3010

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

23572019-01: 0 reports for this device; peer average 1.25/device2019-02: 0 reports for this device; peer average 1.25/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 2.75/device2019-05: 0 reports for this device; peer average 2.38/device2019-06: 0 reports for this device; peer average 1.67/device2019-07: 0 reports for this device; peer average 3.5/device2019-08: 0 reports for this device; peer average 2.5/device2019-09: 0 reports for this device; peer average 3.17/device2019-10: 0 reports for this device; peer average 2.33/device2019-11: 0 reports for this device; peer average 2.75/device2019-12: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 3.33/device2020-02: 0 reports for this device; peer average 1.8/device2020-03: 0 reports for this device; peer average 1.8/device2020-04: 0 reports for this device; peer average 2.25/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 3.33/device2020-07: 0 reports for this device; peer average 2.67/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2.4/device2020-10: 0 reports for this device; peer average 2.67/device2020-11: 0 reports for this device; peer average 1.5/device2020-12: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 3/device2021-03: 0 reports for this device; peer average 2.4/device2021-04: 0 reports for this device; peer average 4.33/device2021-05: 0 reports for this device; peer average 1.67/device2021-06: 0 reports for this device; peer average 2.5/device2021-07: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 3.25/device2021-09: 0 reports for this device; peer average 5/device2021-10: 0 reports for this device; peer average 2.5/device2021-11: 0 reports for this device; peer average 3.33/device2021-12: 0 reports for this device; peer average 2.5/device2022-01: 0 reports for this device; peer average 1.33/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 2.4/device2022-04: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 1.4/device2022-07: 0 reports for this device; peer average 1.33/device2022-08: 0 reports for this device; peer average 2.75/device2022-09: 0 reports for this device; peer average 3/device2022-10: 0 reports for this device; peer average 6/device2022-11: 0 reports for this device; peer average 3.8/device2022-12: 0 reports for this device; peer average 3.5/device2023-01: 0 reports for this device; peer average 3.33/device2023-02: 0 reports for this device; peer average 4/device2023-03: 0 reports for this device; peer average 6.67/device2023-04: 0 reports for this device; peer average 2.93/device2023-05: 0 reports for this device; peer average 4.5/device2023-06: 0 reports for this device; peer average 4/device2023-07: 0 reports for this device; peer average 2.86/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 4/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1.67/device2023-12: 0 reports for this device; peer average 1.25/device2024-01: 0 reports for this device; peer average 1.33/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 1.75/device2024-04: 0 reports for this device; peer average 2.83/device2024-05: 0 reports for this device; peer average 3/device2024-07: 0 reports for this device; peer average 4/device2024-08: 0 reports for this device; peer average 1.5/device2024-09: 0 reports for this device; peer average 1.25/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 2.33/device2024-12: 0 reports for this device; peer average 5/device2025-01: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 1.5/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 3.5/device2025-05: 0 reports for this device; peer average 6.4/device2025-06: 0 reports for this device; peer average 5/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 4.5/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1.25/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 3.14/device2026-01: 0 reports for this device; peer average 2.5/device2026-02: 0 reports for this device; peer average 1.4/device2026-03: 0 reports for this device; peer average 1.75/device2026-04: 0 reports for this device; peer average 1.5/device2026-05: 0 reports for this device; peer average 5/device2026-06: 0 reports for this device; peer average 1.83/device0102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.25
2019-0201.25
2019-0302
2019-0402.75
2019-0502.38
2019-0601.67
2019-0703.5
2019-0802.5
2019-0903.17
2019-1002.33
2019-1102.75
2019-1202
2020-0103.33
2020-0201.8
2020-0301.8
2020-0402.25
2020-0501.5
2020-0603.33
2020-0702.67
2020-0801
2020-0902.4
2020-1002.67
2020-1101.5
2020-1202
2021-0102
2021-0203
2021-0302.4
2021-0404.33
2021-0501.67
2021-0602.5
2021-0701
2021-0803.25
2021-0905
2021-1002.5
2021-1103.33
2021-1202.5
2022-0101.33
2022-0203
2022-0302.4
2022-0402
2022-0503
2022-0601.4
2022-0701.33
2022-0802.75
2022-0903
2022-1006
2022-1103.8
2022-1203.5
2023-0103.33
2023-0204
2023-0306.67
2023-0402.93
2023-0504.5
2023-0604
2023-0702.86
2023-0801
2023-0904
2023-1001
2023-1101.67
2023-1201.25
2024-0101.33
2024-0201.5
2024-0301.75
2024-0402.83
2024-0503
2024-0704
2024-0801.5
2024-0901.25
2024-1002
2024-1102.33
2024-1205
2025-0101.5
2025-0201.5
2025-0301
2025-0403.5
2025-0506.4
2025-0605
2025-0701
2025-0804.5
2025-0901
2025-1001.25
2025-1102
2025-1203.14
2026-0102.5
2026-0201.4
2026-0301.75
2026-0401.5
2026-0505
2026-0601.83
This device (reports/month)Average device in JDQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K935481 — cited as predicate by K120016, K150581, K151848, K151888, K153242, K173579, K180582, K252949

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Pioneer Surgical Technology, Inc.

  • Warning Letter 2010-08-03 Pioneer Surgical Technology Inc.
  • Warning Letter 2010-08-03 Pioneer Surgical Technology Inc.
  • VAI 2024-06-14 Pioneer Surgical Technology Inc. · 2 citations
  • VAI 2024-06-14 Pioneer Surgical Technology Inc. · 2 citations
  • NAI 2023-05-11 Pioneer Surgical Technology Inc. · 0 citations
  • NAI 2023-05-11 Pioneer Surgical Technology Inc. · 0 citations
  • VAI 2017-03-28 Pioneer Surgical Technology Inc. · 7 citations
  • VAI 2017-03-28 Pioneer Surgical Technology Inc. · 7 citations
  • VAI 2016-06-23 Pioneer Surgical Technology Inc. · 1 citations
  • VAI 2016-06-23 Pioneer Surgical Technology Inc. · 1 citations
  • VAI 2014-07-11 Pioneer Surgical Technology Inc. · 1 citations
  • VAI 2014-07-11 Pioneer Surgical Technology Inc. · 1 citations
  • NAI 2012-03-28 Pioneer Surgical Technology Inc. · 0 citations
  • NAI 2012-03-28 Pioneer Surgical Technology Inc. · 0 citations
  • VAI 2010-12-21 Pioneer Surgical Technology Inc. · 6 citations
  • VAI 2010-12-21 Pioneer Surgical Technology Inc. · 6 citations
  • OAI 2010-04-22 Pioneer Surgical Technology Inc. · 10 citations
  • OAI 2010-04-22 Pioneer Surgical Technology Inc. · 10 citations