The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Insall/burstein* Ii Modular Total Knee.
| Device ID | K872379 |
| 510k Number | K872379 |
| Device Name: | INSALL/BURSTEIN* II MODULAR TOTAL KNEE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Max Sherman |
| Correspondent | Max Sherman ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-19 |
| Decision Date | 1987-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024187764 | K872379 | 000 |
| 00889024187030 | K872379 | 000 |
| 00889024187047 | K872379 | 000 |
| 00889024187054 | K872379 | 000 |
| 00889024187061 | K872379 | 000 |
| 00889024187429 | K872379 | 000 |
| 00889024187436 | K872379 | 000 |
| 00889024187443 | K872379 | 000 |
| 00889024187450 | K872379 | 000 |
| 00889024187467 | K872379 | 000 |
| 00889024187474 | K872379 | 000 |
| 00889024187481 | K872379 | 000 |
| 00889024187498 | K872379 | 000 |
| 00889024187504 | K872379 | 000 |
| 00889024188013 | K872379 | 000 |
| 00889024188075 | K872379 | 000 |
| 00889024188136 | K872379 | 000 |
| 00889024187023 | K872379 | 000 |