The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Cmw 1, 2 And 3 Bone Cements.
| Device ID | K053003 |
| 510k Number | K053003 |
| Device Name: | DEPUY CMW 1, 2 AND 3 BONE CEMENTS |
| Classification | Bone Cement |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Natalie S Heck |
| Correspondent | Natalie S Heck DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-26 |
| Decision Date | 2005-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30603295168632 | K053003 | 000 |
| 30603295168625 | K053003 | 000 |
| 30603295168618 | K053003 | 000 |