The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Cemvac Ultra Pre-packed With Depuy 1 Bone Cement.
| Device ID | K021499 |
| 510k Number | K021499 |
| Device Name: | CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 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 | 2002-05-09 |
| Decision Date | 2002-07-24 |
| Summary: | summary |