Arthrex Fiberwire
510(k) K071622
Arthrex Fiberwire is a Class II device made by Arthrex, Inc., cleared under FDA 510(k) K071622 on 3 Jul 2007, 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 | NumberK071622 | Date3 Jul 2007 | StatusActive |
Official records
- FDA 510(k) database K071622
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GAT
- Device class
- Class II
- Regulation
- 21 CFR Part 878.5000
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).
- TEVDEK IPN928577 LSI-100009 by TELEFLEX INCORPORATED
- TELEFLEX IPN000922 H5500 by TELEFLEX INCORPORATED
- Polyester Nonabsorbable Surgical Sutures URP by Cp Medical
- Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture by Teleflex Medical Incorporated
- Fast-Fix Flex by Smith & Nephew, Inc.
- LSI Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model 020999 by LSI Solutions, Inc.
- SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE by Smith & Nephew, Inc.
- FSSB G006PEW by Surgical Specialties México, S. de R.L. de C.V.
- Fumedica-FSSB H17-2718N by Surgical Specialties México, S. de R.L. de C.V.
- MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture by Biomet Manufacturing Corp