← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

OWY — Mesh, Surgical, Collagen, 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
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K251690Arthrex, Inc. · 510k2025-09-30
K252647Embody, Inc. · 510k2025-09-19
K250109Tybr Health · 510k2025-06-06
K243843Kerecis Limited · 510k2025-06-04
K242631Smith & Nephew Inc., Endoscopy Div. · 510k2024-11-26

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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