The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Amk Total Knee System, Patella Component.
| Device ID | K873197 |
| 510k Number | K873197 |
| Device Name: | AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Barry R Sisson |
| Correspondent | Barry R Sisson DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-13 |
| Decision Date | 1987-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295039624 | K873197 | 000 |
| 10603295039617 | K873197 | 000 |
| 10603295039600 | K873197 | 000 |
| 10603295039594 | K873197 | 000 |