The following data is part of a premarket notification filed by Acu-med, Inc. with the FDA for Huene Fixation Screw.
| Device ID | K910193 |
| 510k Number | K910193 |
| Device Name: | HUENE FIXATION SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ACU-MED, INC. 10950 SW 5TH, SUITE 170 Beaveton, OR 97005 |
| Contact | Randall Huebner |
| Correspondent | Randall Huebner ACU-MED, INC. 10950 SW 5TH, SUITE 170 Beaveton, 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 | 1991-01-16 |
| Decision Date | 1991-08-23 |