The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Acufit Total Hip.
| Device ID | K904383 |
| 510k Number | K904383 |
| Device Name: | ACUFIT TOTAL HIP |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| 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 | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-26 |
| Decision Date | 1990-12-20 |