Arthrex Compression Screws
510(k) K201132
Arthrex Compression Screws is a Class II device made by Arthrex, Inc., cleared under FDA 510(k) K201132 on 27 Jul 2020, active as of 22 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 | NumberK201132 | Date27 Jul 2020 | StatusActive |
Official records
- FDA 510(k) database K201132
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRS
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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