Low Profile Screws
510(k) K103705
Low Profile Screws is a Class II device made by Arthrex, Inc., cleared under FDA 510(k) K103705 on 18 Mar 2011, 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 | NumberK103705 | Date18 Mar 2011 | StatusActive |
Official records
- FDA 510(k) database K103705
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HWC
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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