The following data is part of a premarket notification filed by United American Medical Co., Inc. with the FDA for Small Bone Fixation System.
Device ID | K911929 |
510k Number | K911929 |
Device Name: | SMALL BONE FIXATION SYSTEM |
Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
Applicant | UNITED AMERICAN MEDICAL CO., INC. 216 E. MAIN ST. P.O. BOX 308 Mc Minnville, TN 37110 |
Contact | Thomas L Walling |
Correspondent | Thomas L Walling UNITED AMERICAN MEDICAL CO., INC. 216 E. MAIN ST. P.O. BOX 308 Mc Minnville, TN 37110 |
Product Code | HWE |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-30 |
Decision Date | 1991-07-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SMALL BONE FIXATION SYSTEM 78784347 not registered Dead/Abandoned |
Small Bone Innovations, LLC 2006-01-03 |