Versabond Bone Cement
510(k) K001160
Versabond Bone Cement is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K001160 on 11 Dec 2000, 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 | NumberK001160 | Date11 Dec 2000 | StatusActive |
Official records
- FDA 510(k) database K001160
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LOD
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3027
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K001160
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| VERSABOND 71271140 | 71271140 / 71271140 | 03596010411020 | — | On the market |
Similar devices
Other devices filed under FDA product code LOD (Bone Cement).
- SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII by Stryker Corp.
- G1 40 Radiopaque Bone Cement by G21 S.R.L.
- PALACOS fast R+G by Heraeus Medical LLC
- CEMEX SYSTEM 80G 1500/S by Tecres
- OSTEOPAL® V 66031896 by Heraeus Medical LLC
- CEMEX SYSTEM GENTA FAST BONE CEMENT by Exactech, Inc.
- CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT by DEPUY ORTHOPAEDICS, INC.
- Bone Cement Genta, Bone Cement HV, Bone Cement LV by Tecres S.p.A.
- PALAMED G by Heraeus Kulzer, Inc.
- CEMEX SYSTEM 60G 1310/S by Tecres