The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Lps Proximal Tibial Component.
| Device ID | K062301 |
| 510k Number | K062301 |
| Device Name: | DEPUY LPS PROXIMAL TIBIAL COMPONENT |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Nancy Friddle |
| Correspondent | Nancy Friddle DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-08 |
| Decision Date | 2006-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295079071 | K062301 | 000 |