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Daytona Small Stature

Model 76-0313 · Seaspine Orthopedics Corporation · DI 10889981152840

PGM — Growing Rod System · Class II · 21 CFR 888.3070

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.

12232022-03: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 3/device2025-12: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 2/device03070103041203
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-0301
2023-0701
2025-0102
2025-0301
2025-0403
2025-1201.5
2026-0302
This device (reports/month)Average device in PGM (reports/device/month)

Regulatory clearances

  • K193224 SESE 2020-02-13 (k number procode)

Predicate lineage

K193224 — cites (transitively): K142114 (d1), K121342 (d2), K133904 (d2) — cited as predicate by K232566

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

Manufacturer compliance record — Seaspine Orthopedics Corporation

  • Warning Letter 2026-02-24 IsoTis OrthoBiologics, Inc.
  • OAI 2025-10-17 IsoTis OrthoBiologics, Inc. · 3 citations
  • NAI 2022-04-22 SEASPINE ORTHOPEDICS CORPORATION · 0 citations
  • NAI 2022-04-22 SEASPINE ORTHOPEDICS CORPORATION · 0 citations
  • NAI 2018-08-14 SEASPINE ORTHOPEDICS CORPORATION · 0 citations
  • NAI 2018-08-14 SEASPINE ORTHOPEDICS CORPORATION · 0 citations
  • NAI 2015-09-25 IsoTis OrthoBiologics, Inc. · 0 citations
  • NAI 2012-04-27 IsoTis OrthoBiologics, Inc. · 0 citations