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FDA PRODUCT CODE · CLASS II

OWW — Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

For reinforcement of soft tissue where weakness exists during tendon repair procedures.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.3300
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K251655Alafair Biosciences · 510k2025-07-18
K250021Nanofiber Solutions, LLC · 510k2025-02-27
K242187Conmed Corporation · 510k2024-11-27

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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