Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K043410
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K043410
Device Name
Screw, Fixation, Bone
Applicant
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
3150 E. 200TH ST.
PRIOR LAKE, MN 55372 US
Other 510(k) Applications for this Company
Contact
AL LIPPINCOTT
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/2004
Decision Date
02/24/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact