The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Bone Fixation Nail.
| Device ID | K943855 |
| 510k Number | K943855 |
| Device Name: | BONE FIXATION NAIL |
| Classification | Nail, Fixation, Bone |
| 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 | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-08 |
| Decision Date | 1995-07-12 |