The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Techmedica 6.5mm Self-tapping Cancellous Bone Scre.
| Device ID | K926579 |
| 510k Number | K926579 |
| Device Name: | TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE |
| Classification | Screw, Fixation, Bone |
| Applicant | TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
| Contact | Candace Cobos |
| Correspondent | Candace Cobos 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 | 1992-11-24 |
| Decision Date | 1993-04-06 |