The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Acutract.
Device ID | K930834 |
510k Number | K930834 |
Device Name: | ACUTRACT |
Classification | Screw, Fixation, Bone |
Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
Contact | Gene Conrad |
Correspondent | Gene Conrad ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-17 |
Decision Date | 1993-07-26 |