Device Classification Name |
nail, fixation, bone
|
510(k) Number |
K072095 |
Device Name |
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS |
Applicant |
SYNTHES (USA) |
1301 GOSHEN PKWY. |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
JILL SHERMAN |
Correspondent |
SYNTHES (USA) |
1301 GOSHEN PKWY. |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
JILL SHERMAN |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 07/31/2007 |
Decision Date | 09/27/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|