The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Bio-fit Hip System.
| Device ID | K854791 |
| 510k Number | K854791 |
| Device Name: | BIO-FIT HIP SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| 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 | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-29 |
| Decision Date | 1986-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010196491 | K854791 | 000 |
| 03596010196484 | K854791 | 000 |
| 03596010196439 | K854791 | 000 |
| 03596010196422 | K854791 | 000 |
| 03596010009791 | K854791 | 000 |
| 03596010009784 | K854791 | 000 |
| 03596010009777 | K854791 | 000 |
| 03596010009760 | K854791 | 000 |