Device Classification Name |
Rod, Fixation, Intramedullary And Accessories
|
510(k) Number |
K082148 |
Device Name |
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION |
Applicant |
SYNTHES (USA) |
1301 GOSHEN PKWY. |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
JILL R SHERMAN |
Correspondent |
SYNTHES (USA) |
1301 GOSHEN PKWY. |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
JILL R SHERMAN |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 07/30/2008 |
Decision Date | 08/11/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|