The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Rogozinski Spinal System, Add'l Components.
| Device ID | K896106 |
| 510k Number | K896106 |
| Device Name: | ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-20 |
| Decision Date | 1990-06-25 |