Device Classification Name |
prosthesis, finger, constrained, polymer
|
510(k) Number |
K220142 |
Device Name |
BRM Digitalis Spacer |
Applicant |
BRM Extremities Srl |
Via Papa Giovanni XXIII, 9 |
Civate,
IT
23862
|
|
Applicant Contact |
Andrea De Maglio |
Correspondent |
Mcra, LLC |
803 7th Street NW |
Washington,
DC
20001
|
|
Correspondent Contact |
Margeaux Rogers |
Regulation Number | 888.3230
|
Classification Product Code |
|
Date Received | 01/18/2022 |
Decision Date | 04/04/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|