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FDA 510(k) Application Details - K990454
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K990454
Device Name
Screw, Fixation, Bone
Applicant
INNOVASIVE DEVICES, INC.
734 FOREST ST.
MARLBOROUGH, MA 01752 US
Other 510(k) Applications for this Company
Contact
KATHLEEN MORAHAN
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
02/12/1999
Decision Date
07/01/1999
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
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