The following data is part of a premarket notification filed by Orthopedic Equipment Co., Inc. with the FDA for Universal Self-aligning Acetabular Com.
| Device ID | K834035 |
| 510k Number | K834035 |
| Device Name: | UNIVERSAL SELF-ALIGNING ACETABULAR COM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ORTHOPEDIC EQUIPMENT CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-23 |
| Decision Date | 1984-06-19 |