The following data is part of a premarket notification filed by Creative Medical Designs, Inc. with the FDA for Rayhack Osteotomy System (modification).
| Device ID | K952766 |
| 510k Number | K952766 |
| Device Name: | RAYHACK OSTEOTOMY SYSTEM (MODIFICATION) |
| Classification | Plate, Fixation, Bone |
| Applicant | CREATIVE MEDICAL DESIGNS, INC. 13914 SHADY SHORES DR. Tampa, FL 33613 |
| Contact | John M Rayhack |
| Correspondent | John M Rayhack CREATIVE MEDICAL DESIGNS, INC. 13914 SHADY SHORES DR. Tampa, FL 33613 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-31 |
| Decision Date | 1995-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420143426 | K952766 | 000 |
| 00840420143389 | K952766 | 000 |