The following data is part of a premarket notification filed by Hexcel Medical with the FDA for Brigham Ii Total Hip System.
| Device ID | K812687 |
| 510k Number | K812687 |
| Device Name: | BRIGHAM II TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Applicant | HEXCEL MEDICAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDG |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-22 |
| Decision Date | 1981-10-02 |