The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Cancellous Bone-l.p. And Cortical Bone Screw.
| Device ID | K915187 |
| 510k Number | K915187 |
| Device Name: | CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
| Contact | Richard W Cudworth |
| Correspondent | Richard W Cudworth TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-18 |
| Decision Date | 1991-12-19 |