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FDA 510(k) Application Details - K992106
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K992106
Device Name
Screw, Fixation, Bone
Applicant
MEDARTIS AG
1601 TRAPELO RD.
RESERVOIR PLACE
WALTHAM, MA 02451 US
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Contact
LINDA JALBERT
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
06/22/1999
Decision Date
09/17/1999
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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