The following data is part of a premarket notification filed by Retrofix Screws, Llc with the FDA for Retrofix.
Device ID | K200226 |
510k Number | K200226 |
Device Name: | RetroFix |
Classification | Screw, Fixation, Bone |
Applicant | Retrofix Screws, LLC 1035 Lincolnton Road Salisbury, NC 28144 |
Contact | Keith A Barritt |
Correspondent | Keith A Barritt Fish & Richardson P.C. 1000 Maine Avenue, S.W. Suite 1000 Washington, DC 20024 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-01-30 |
Decision Date | 2020-06-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RETROFIX 88357047 not registered Live/Pending |
RetroFix Screws, LLC 2019-03-26 |
RETROFIX 78918924 not registered Dead/Abandoned |
Equipment Brokers, Inc. 2006-06-28 |