← FDA Medical Device Classifications
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
OWX · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.3300
Classification
- FDA Product Code
OWX- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.3300
- Review panel
- OR
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
For reinforcement of soft tissue where weakness exists in tendon repair.
Market data
- Cleared 510(k) submissions
- 5
- Registered establishments
- 14
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown