The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Bone Screw 3.5 Mm.
| Device ID | K915613 |
| 510k Number | K915613 |
| Device Name: | BONE SCREW 3.5 MM |
| Classification | Screw, Fixation, Bone |
| Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Contact | Randall Huebner |
| Correspondent | Randall Huebner ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-16 |
| Decision Date | 1992-02-13 |