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510(k) K120390

SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET by Solana Surgical, LLC — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2012
Date Received
February 7, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K113752 — METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET (February 6, 2012)
  • K090127 — METATARSAL DECOMPRESSION IMPLANT, MODEL 100 (May 1, 2009)

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