Device Classification Name |
prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained
|
510(k) Number |
K200718 |
Device Name |
Arthrosurface WristMotion Total Wrist Arthroplasty System |
Applicant |
Arthrosurface, Inc. |
28 Forge Parkway |
Franklin,
MA
02038
|
|
Applicant Contact |
Dawn J. Wilson |
Correspondent |
Arthrosurface, Inc. |
28 Forge Parkway |
Franklin,
MA
02038
|
|
Correspondent Contact |
Dawn J. Wilson |
Regulation Number | 888.3800
|
Classification Product Code |
|
Date Received | 03/19/2020 |
Decision Date | 10/15/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|