The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Insall/burstein Constrained Total Condyl.
| Device ID | K810520 |
| 510k Number | K810520 |
| Device Name: | INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | ZIMMER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-26 |
| Decision Date | 1981-03-26 |