The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Lps Upper Extremity.
| Device ID | K042664 |
| 510k Number | K042664 |
| Device Name: | LPS UPPER EXTREMITY |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Tiffani D Rogers |
| Correspondent | Tiffani D Rogers DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-28 |
| Decision Date | 2004-12-08 |
| Summary: | summary |