The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Versabond Bone Cement.
| Device ID | K001160 |
| 510k Number | K001160 |
| Device Name: | VERSABOND BONE CEMENT |
| Classification | Bone Cement |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Ehab M Esmail |
| Correspondent | Ehab M Esmail SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 23596010411024 | K001160 | 000 |