The following data is part of a premarket notification filed by Rms Div. with the FDA for Rms K-wire.
| Device ID | K963367 |
| 510k Number | K963367 |
| Device Name: | RMS K-WIRE |
| Classification | Pin, Fixation, Smooth |
| Applicant | RMS DIV. 8600 EVERGREEN BLVD. Minneapolis, MN 55433 -6036 |
| Contact | Jodi Locher |
| Correspondent | Jodi Locher RMS DIV. 8600 EVERGREEN BLVD. Minneapolis, MN 55433 -6036 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-27 |
| Decision Date | 1996-10-30 |