The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Spectron Primary Stem Femoral Prosthes.
| Device ID | K823727 |
| 510k Number | K823727 |
| Device Name: | SPECTRON PRIMARY STEM FEMORAL PROSTHES |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | RICHARD'S MEDICAL EQUIP., 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 | 1982-12-10 |
| Decision Date | 1983-03-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010462176 | K823727 | 000 |
| 03596010462039 | K823727 | 000 |
| 03596010462046 | K823727 | 000 |
| 03596010462145 | K823727 | 000 |
| 03596010462152 | K823727 | 000 |
| 03596010462169 | K823727 | 000 |
| 03596010462183 | K823727 | 000 |
| 03596010473400 | K823727 | 000 |
| 03596010462008 | K823727 | 000 |
| 03596010462015 | K823727 | 000 |
| 03596010462022 | K823727 | 000 |