The following data is part of a premarket notification filed by Brasseler Usa I, L.p. with the FDA for Kirschner (k-wire), Steinman Pins.
| Device ID | K945670 |
| 510k Number | K945670 |
| Device Name: | KIRSCHNER (K-WIRE), STEINMAN PINS |
| Classification | Pin, Fixation, Threaded |
| Applicant | BRASSELER USA I, L.P. 800 KING GEORGE BLVD. Savannah, GA 31419 |
| Contact | Courtney S Paradice |
| Correspondent | Courtney S Paradice BRASSELER USA I, L.P. 800 KING GEORGE BLVD. Savannah, GA 31419 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-18 |
| Decision Date | 1995-03-07 |