VersaWrap Tendon Protector
by Alafair Biosciences, Inc. 2 variants
510(k) K160364
VersaWrap Tendon Protector is a Class II device made by Alafair Biosciences, Inc., cleared under FDA 510(k) K160364 on 10 Jun 2016, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160364 | Date10 Jun 2016 | StatusActive |
Official records
- FDA 510(k) database K160364
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OWW
- Device class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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