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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057717555400 | K203773 | 000 |
| 08057717551846 | K203773 | 000 |
| 08057717551822 | K203773 | 000 |
| 08057717551808 | K203773 | 000 |
| 08057717551785 | K203773 | 000 |
| 08057717551761 | K203773 | 000 |
| 08057717551754 | K203773 | 000 |
| 08057717551747 | K203773 | 000 |
| 08057717551723 | K203773 | 000 |
| 08057717550603 | K203773 | 000 |
| 08057717551860 | K203773 | 000 |
| 08057717551884 | K203773 | 000 |
| 08057717551907 | K203773 | 000 |
| 08057717555394 | K203773 | 000 |
| 08057717554106 | K203773 | 000 |
| 08057717552690 | K203773 | 000 |
| 08057717552652 | K203773 | 000 |
| 08057717552003 | K203773 | 000 |
| 08057717551990 | K203773 | 000 |
| 08057717551976 | K203773 | 000 |
| 08057717551945 | K203773 | 000 |
| 08057717551921 | K203773 | 000 |
| 08057717550054 | K203773 | 000 |