The following data is part of a premarket notification filed by Brm Extremities Srl with the FDA for Brm Tool Screws.
Device ID | K203773 |
510k Number | K203773 |
Device Name: | BRM TOOL Screws |
Classification | Screw, Fixation, Bone |
Applicant | BRM Extremities Srl Via Papa Giovanni XXIII, 9 Civate, IT 23862 |
Contact | Andrea De Maglio |
Correspondent | Margeaux Rogers MCRA, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-12-23 |
Decision Date | 2022-01-14 |