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510(k) K111667

SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS by Synthes (Usa) — Product Code JDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2011
Date Received
June 14, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nail, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR (May 25, 2012)
  • K111540 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (August 8, 2011)
  • K110789 — SYNTHES STERNAL ZIPFIX SYSTEM (July 28, 2011)
  • K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (March 2, 2011)
  • K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (January 21, 2011)
  • K102656 — SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM (December 20, 2010)

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