The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Spectron Proximal Femoral Prosthesis.
| Device ID | K823723 |
| 510k Number | K823723 |
| Device Name: | SPECTRON PROXIMAL FEMORAL PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-10 |
| Decision Date | 1983-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556046616 | K823723 | 000 |
| 00885556045435 | K823723 | 000 |
| 03596010483713 | K823723 | 000 |
| 03596010483706 | K823723 | 000 |
| 03596010483690 | K823723 | 000 |