Data / Medical devices / Italy / BRM Extremities SRL
BRM Extremities SRL: FDA-registered device maker in Civate (LC) Lombardy, Italy, 4 510(k) clearances
BRM Extremities SRL is registered with the FDA (registration 3016669046) in Civate (LC) Lombardy, Italy. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 4, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016669046
- Address
- Via Privata ai Campi, 7, Civate (LC) Lombardy, Italy, 23862
- Owner or operator
- BRM EXTREMITIES (10062707)
- Roles
- Manufacturer
- First device listed
- March 10, 2020
- Registered through
- 2027
- Brand names listed
- BRM BIOPLAN SUBTALAR IMPLANT, BRM DIGITALIS Spacer, BRM DRILL BIT, BRM TOOL PRO 5.6 SCREWS, BRM TOOL PRO 7 SCREWS, BRM TOOL SCREWS, BRM TOOL VIP SCREWS, BRM VR BREAKING SCREWS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Burr, Orthopedic | HTT | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Finger, Constrained, Polymer | KYJ | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Toe, Constrained, Polymer | KWH | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 4, 2023 | K220142 | BRM Digitalis Spacer | KYJ | Substantially Equivalent | Brm Extremities Srl | accessdata.fda.gov |
| December 16, 2022 | K222820 | BRM TOOL Screws, BIOPLAN Subtalar Implant | HWC | Substantially Equivalent | Brm Extremities | accessdata.fda.gov |
| January 14, 2022 | K203773 | BRM TOOL Screws | HWC | Substantially Equivalent | Brm Extremities Srl | accessdata.fda.gov |
| February 13, 2020 | K191966 | NewPrim System | KWH | Substantially Equivalent | Brm Extremities | accessdata.fda.gov |
Compare with other makers
- All makers of Bit, Drill
- All makers of Prosthesis, Finger, Constrained, Polymer
- All makers of Burr, Orthopedic
- All makers of Screw, Fixation, Bone
- All makers of Prosthesis, Toe, Constrained, Polymer
- All makers of Orthopedic Manual Surgical Instrument
Updated April 4, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.