The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Lps Universal Tibial Hinge Inserts, Model 198727012-198727331.
| Device ID | K091453 |
| 510k Number | K091453 |
| Device Name: | LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Suzana Otano |
| Correspondent | Suzana Otano DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-18 |
| Decision Date | 2009-08-12 |
| Summary: | summary |