Device Classification Name |
pin, fixation, smooth
|
510(k) Number |
K092038 |
Device Name |
APTUS K-WIRE SYSTEM |
Applicant |
MEDARTIS AG |
11234 EL CAMINO REAL, STE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
KEVIN THOMAS |
Correspondent |
MEDARTIS AG |
11234 EL CAMINO REAL, STE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
KEVIN THOMAS |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 07/06/2009 |
Decision Date | 09/23/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|