← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

OWX — Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon

For reinforcement of soft tissue where weakness exists in tendon repair.

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
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K253867ZuriMED Technologies AG · 510k2026-01-02
K250997Anika Therapeutics, Inc. · 510k2025-06-17
K243480Arthrex, Inc. · 510k2025-05-29
K241219ZuriMED Technologies AG · 510k2024-12-11

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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