The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Modular Range Of Ring Pros. For Hip Replacement.
| Device ID | K871956 |
| 510k Number | K871956 |
| Device Name: | MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | DOWNS SURGICAL LTD. CHURCH PATH Mitcham Surrey, GB |
| Contact | Geoffrey W Down |
| Correspondent | Geoffrey W Down DOWNS SURGICAL LTD. CHURCH PATH Mitcham Surrey, GB |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-20 |
| Decision Date | 1987-06-23 |