The following data is part of a premarket notification filed by Hexcel Medical with the FDA for Condylar Knee W/metal Encapsulated Tib.
| Device ID | K810230 |
| 510k Number | K810230 |
| Device Name: | CONDYLAR KNEE W/METAL ENCAPSULATED TIB |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | HEXCEL MEDICAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-27 |
| Decision Date | 1981-03-06 |