The following data is part of a premarket notification filed by Hexcel Medical with the FDA for Knee System, Quadraxial Constrained.
| Device ID | K781971 |
| 510k Number | K781971 |
| Device Name: | KNEE SYSTEM, QUADRAXIAL CONSTRAINED |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | HEXCEL MEDICAL 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 | 1978-11-27 |
| Decision Date | 1979-04-04 |