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FDA 510(k) Application Details - K100457
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K100457
Device Name
Screw, Fixation, Bone
Applicant
ARTHROCARE CORP.
15285 ALTON PARKWAY, #200
IRVINE, CA 92618 US
Other 510(k) Applications for this Company
Contact
LAURA N KASPEROWICZ
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
02/17/2010
Decision Date
03/19/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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