The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Duracon Inset Patella, 25mm.
| Device ID | K993692 |
| 510k Number | K993692 |
| Device Name: | DURACON INSET PATELLA, 25MM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Terry Sheridan Powell |
| Correspondent | Terry Sheridan Powell HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-02 |
| Decision Date | 1999-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613153132738 | K993692 | 000 |