The following data is part of a premarket notification filed by Hayes Medical, Inc. with the FDA for Corticellous Bone Screw.
| Device ID | K953198 |
| 510k Number | K953198 |
| Device Name: | CORTICELLOUS BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | HAYES MEDICAL, INC. 819 STRIKER AVE. SUITE 10 Sacramento, CA 95834 -1129 |
| Contact | Brian T Cleary |
| Correspondent | Brian T Cleary HAYES MEDICAL, INC. 819 STRIKER AVE. SUITE 10 Sacramento, CA 95834 -1129 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-06 |
| Decision Date | 1995-11-24 |