The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Hartford Total Hip System (tri-wedge).
| Device ID | K870128 |
| 510k Number | K870128 |
| Device Name: | HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robert F Games |
| Correspondent | Robert F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-12 |
| Decision Date | 1987-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010087515 | K870128 | 000 |
| 03596010087362 | K870128 | 000 |
| 03596010087379 | K870128 | 000 |
| 03596010087386 | K870128 | 000 |
| 03596010087393 | K870128 | 000 |
| 03596010087409 | K870128 | 000 |
| 03596010087416 | K870128 | 000 |
| 03596010087492 | K870128 | 000 |
| 03596010087508 | K870128 | 000 |
| 03596010087355 | K870128 | 000 |