The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Lps Metaphyseal Sleeve (limb Preservation System).
| Device ID | K040281 |
| 510k Number | K040281 |
| Device Name: | LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM) |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Dina L Weissman |
| Correspondent | Dina L Weissman DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-06 |
| Decision Date | 2004-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295078500 | K040281 | 000 |
| 10603295078494 | K040281 | 000 |
| 10603295078487 | K040281 | 000 |