The following data is part of a premarket notification filed by Tava Surgical Instruments with the FDA for Tava K-wire.
| Device ID | K940109 |
| 510k Number | K940109 |
| Device Name: | TAVA K-WIRE |
| Classification | Pin, Fixation, Smooth |
| Applicant | TAVA SURGICAL INSTRUMENTS 1715 SURVEYOR AVE. Simi Valley, CA 93063 |
| Contact | David Vanderhorst |
| Correspondent | David Vanderhorst TAVA SURGICAL INSTRUMENTS 1715 SURVEYOR AVE. Simi Valley, CA 93063 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-10 |
| Decision Date | 1994-02-22 |