Link Acetabular Mesh
by WALDEMAR LINK GmbH & Co. KG
510(k) K844225
Link Acetabular Mesh is a Class II device made by WALDEMAR LINK GmbH & Co. KG, cleared under FDA 510(k) K844225 on 14 Nov 1984, 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 | NumberK844225 | Date14 Nov 1984 | StatusActive |
Official records
- FDA 510(k) database K844225
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FTM
- Device class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code FTM (Mesh, Surgical).
- SURGISIS RVP RECTO-VAGINAL FISTULA PLUG by Cook Biotech, Inc.
- DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT by DEPUY ORTHOPAEDICS, INC.
- ZIMMER COLLAGEN REPAIR PATCH by Tissue Science Laboratories, Plc
- PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX by Brennen Medical, LLC
- FORTAFLEX SURGICAL SLING by ORGANOGENESIS INC.
- Endoform Reconstructive Template by Aroa Biosurgery Limited (Formerly Mesynthes Limited)
- Miromatrix Biological Mesh TW by Miromatrix Medical, Inc.
- SIS DERMAL AUGMENTATION STRAND by Cook Biotech, Inc.
- SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. by Shelhigh, Inc.
- TissueMend® 6495-9-001 by TEI BIOSCIENCES INC.