The following data is part of a premarket notification filed by Synvasive Technology, Inc. with the FDA for Kirschner Wire (k-wire) And Steinmann Pin.
| Device ID | K961522 |
| 510k Number | K961522 |
| Device Name: | KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN |
| Classification | Pin, Fixation, Smooth |
| Applicant | SYNVASIVE TECHNOLOGY, INC. 4925 ROBERT J. MATHEWS PKWY. El Dorado Hills, CA 95762 |
| Contact | Michael G Fisher |
| Correspondent | Michael G Fisher SYNVASIVE TECHNOLOGY, INC. 4925 ROBERT J. MATHEWS PKWY. El Dorado Hills, CA 95762 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-22 |
| Decision Date | 1996-09-23 |
| Summary: | summary |