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

Particulate 1.0cc

Model NB0701 · NOVABONE PRODUCTS, LLC · DI 00813909011943

MQV — Filler, Bone Void, Calcium Compound · Class II · 21 CFR 888.3045

UDILibrary device dossier · generated 2026-09-07 · 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.

13462019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 2.2/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1.25/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1.25/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1.67/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1.5/device2021-05: 0 reports for this device; peer average 1.5/device2021-06: 0 reports for this device; peer average 1.5/device2021-07: 0 reports for this device; peer average 2.2/device2021-08: 0 reports for this device; peer average 1.75/device2021-09: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 2.25/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 3.5/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 3/device2022-08: 0 reports for this device; peer average 1.5/device2022-09: 0 reports for this device; peer average 2.33/device2022-10: 0 reports for this device; peer average 5.8/device2022-11: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 1.5/device2023-03: 0 reports for this device; peer average 4.5/device2023-04: 0 reports for this device; peer average 1.75/device2023-05: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1.5/device2023-08: 0 reports for this device; peer average 1.33/device2023-09: 0 reports for this device; peer average 4/device2024-01: 0 reports for this device; peer average 3/device2024-02: 0 reports for this device; peer average 1.2/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 1.6/device2024-08: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1.67/device2025-03: 0 reports for this device; peer average 1.67/device2025-04: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 5.25/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1.5/device2025-12: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1.88/device2026-02: 0 reports for this device; peer average 1.33/device2026-03: 0 reports for this device; peer average 1.2/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 2.5/device2026-06: 0 reports for this device; peer average 1/device010205070911120102030405060708091011120203040506070809101112010203040506080910110102030405070809010203040506070812010304060708091112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0202
2019-0503
2019-0701
2019-0901
2019-1101
2019-1202.2
2020-0101
2020-0201
2020-0301
2020-0401.25
2020-0501
2020-0601
2020-0701
2020-0801
2020-0901
2020-1001.25
2020-1101
2020-1201
2021-0201.67
2021-0302
2021-0401.5
2021-0501.5
2021-0601.5
2021-0702.2
2021-0801.75
2021-0901
2021-1001
2021-1103
2021-1202.25
2022-0101
2022-0203
2022-0303.5
2022-0401
2022-0501
2022-0603
2022-0801.5
2022-0902.33
2022-1005.8
2022-1102
2023-0102
2023-0201.5
2023-0304.5
2023-0401.75
2023-0501
2023-0701.5
2023-0801.33
2023-0904
2024-0103
2024-0201.2
2024-0302
2024-0402
2024-0501
2024-0602
2024-0701.6
2024-0802
2024-1201
2025-0101.67
2025-0301.67
2025-0401
2025-0605.25
2025-0702
2025-0802
2025-0901
2025-1101.5
2025-1201
2026-0101.88
2026-0201.33
2026-0301.2
2026-0401
2026-0502.5
2026-0601
This device (reports/month)Average device in MQV (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K052494 — cited as predicate by K151154, K242782

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

Manufacturer compliance record — NOVABONE PRODUCTS, LLC

  • VAI 2015-03-20 NovaBone Products LLC · 6 citations
  • VAI 2015-03-20 NovaBone Products LLC · 6 citations
  • NAI 2011-11-03 NovaBone Products LLC · 0 citations
  • NAI 2011-11-03 NovaBone Products LLC · 0 citations