Device Classification Name |
prosthesis, elbow, hemi-, radial, polymer
|
510(k) Number |
K092721 |
Device Name |
ALIGN RADIAL HEAD SYSTEM |
Applicant |
SKELETAL DYNAMICS, LLC |
80 SHELDON TECHNOLOGY CENTER |
SHELTON,
CT
06484
|
|
Applicant Contact |
JOSEPH AZARY |
Correspondent |
SKELETAL DYNAMICS, LLC |
80 SHELDON TECHNOLOGY CENTER |
SHELTON,
CT
06484
|
|
Correspondent Contact |
JOSEPH AZARY |
Regulation Number | 888.3170
|
Classification Product Code |
|
Date Received | 09/04/2009 |
Decision Date | 08/03/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|