The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Fixation Pins/wires.
| Device ID | K943856 |
| 510k Number | K943856 |
| Device Name: | FIXATION PINS/WIRES |
| Classification | Pin, Fixation, Smooth |
| Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Contact | Shari L Jeffers |
| Correspondent | Shari L Jeffers ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-08 |
| Decision Date | 1995-07-06 |