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510(k) K124045

FUSEFORCE IMPLANT SYSTEM by Solana Surgical, LLC — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2013
Date Received
December 31, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K120029 — HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET (February 6, 2012)
  • K090127 — METATARSAL DECOMPRESSION IMPLANT, MODEL 100 (May 1, 2009)

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