Device Classification Name |
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
|
510(k) Number |
K123380 |
Device Name |
STRIDE UNICONDYLAR KNEE |
Applicant |
BLUE BELT TECHNOLOGIES, INC. |
2828 LIBERTY AVENUE |
SUITE 100 |
PITTSBURGH,
PA
15222
|
|
Applicant Contact |
RICK CONFER |
Correspondent |
BLUE BELT TECHNOLOGIES, INC. |
2828 LIBERTY AVENUE |
SUITE 100 |
PITTSBURGH,
PA
15222
|
|
Correspondent Contact |
RICK CONFER |
Regulation Number | 888.3520
|
Classification Product Code |
|
Date Received | 11/01/2012 |
Decision Date | 05/31/2013 |
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
|
|
|