Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K093868 |
Device Name |
I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM |
Applicant |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
3150 E. 200TH ST. |
PRIOR LAKE,
MN
55372
|
|
Applicant Contact |
AL LIPPINCOTT |
Correspondent |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
3150 E. 200TH ST. |
PRIOR LAKE,
MN
55372
|
|
Correspondent Contact |
AL LIPPINCOTT |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/17/2009 |
Decision Date | 08/05/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|