The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy 1 Gentamicin Bone Cement.
| Device ID | K023103 |
| 510k Number | K023103 |
| Device Name: | DEPUY 1 GENTAMICIN BONE CEMENT |
| Classification | Bone Cement |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-18 |
| Decision Date | 2003-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20603295174261 | K023103 | 000 |