The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Insall/burstein(tm)* Ii Tibial Wedges.
| Device ID | K862632 |
| 510k Number | K862632 |
| Device Name: | INSALL/BURSTEIN(TM)* II TIBIAL WEDGES |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, 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 | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-10 |
| Decision Date | 1987-03-25 |