Device Classification Name |
Cerclage, Fixation
|
510(k) Number |
K121541 |
Device Name |
JAZZ SYSTEM |
Applicant |
IMPLANET S.A. |
1835 MARKET ST. |
29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Applicant Contact |
JANICE M HOGAN |
Correspondent |
IMPLANET S.A. |
1835 MARKET ST. |
29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Correspondent Contact |
JANICE M HOGAN |
Regulation Number | 888.3010
|
Classification Product Code |
|
Date Received | 05/24/2012 |
Decision Date | 09/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|