The following data is part of a premarket notification filed by Biomedics with the FDA for Biometric Total Hip System.
| Device ID | K844787 |
| 510k Number | K844787 |
| Device Name: | BIOMETRIC TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMEDICS 4477 HOLLYWOOD BLVD. Los Angeles, CA 90027 |
| Contact | Paul M Guyer |
| Correspondent | Paul M Guyer BIOMEDICS 4477 HOLLYWOOD BLVD. Los Angeles, CA 90027 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-10 |
| Decision Date | 1985-04-19 |