The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Universal Gription Tf Cones.
| Device ID | K100391 |
| 510k Number | K100391 |
| Device Name: | DEPUY UNIVERSAL GRIPTION TF CONES |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Dawn Sinclair, Ma |
| Correspondent | Dawn Sinclair, Ma DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | JWH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KRO |
| Subsequent Product Code | KWA |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295010142 | K100391 | 000 |
| 10603295009023 | K100391 | 000 |
| 10603295009016 | K100391 | 000 |
| 10603295009009 | K100391 | 000 |
| 10603295008996 | K100391 | 000 |
| 10603295008989 | K100391 | 000 |
| 10603295008521 | K100391 | 000 |
| 10603295008514 | K100391 | 000 |
| 10603295008507 | K100391 | 000 |
| 10603295008491 | K100391 | 000 |
| 10603295008484 | K100391 | 000 |
| 10603295008477 | K100391 | 000 |
| 10603295008460 | K100391 | 000 |
| 10603295008453 | K100391 | 000 |
| 10603295008446 | K100391 | 000 |
| 10603295008439 | K100391 | 000 |
| 10603295008422 | K100391 | 000 |
| 10603295009030 | K100391 | 000 |
| 10603295009245 | K100391 | 000 |
| 10603295010135 | K100391 | 000 |
| 10603295010128 | K100391 | 000 |
| 10603295010111 | K100391 | 000 |
| 10603295010104 | K100391 | 000 |
| 10603295010098 | K100391 | 000 |
| 10603295009788 | K100391 | 000 |
| 10603295009771 | K100391 | 000 |
| 10603295009764 | K100391 | 000 |
| 10603295009757 | K100391 | 000 |
| 10603295009740 | K100391 | 000 |
| 10603295009733 | K100391 | 000 |
| 10603295009290 | K100391 | 000 |
| 10603295009283 | K100391 | 000 |
| 10603295009276 | K100391 | 000 |
| 10603295009269 | K100391 | 000 |
| 10603295009252 | K100391 | 000 |
| 10603295008415 | K100391 | 000 |