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510(k) K132594

CROSSCHECK PLATING SYSTEM by Solana Surgical, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2013
Date Received
August 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Solana Surgical, LLC

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  • K120390 — SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET (April 10, 2012)
  • K120029 — HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET (February 6, 2012)
  • K113752 — METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET (February 6, 2012)
  • K090127 — METATARSAL DECOMPRESSION IMPLANT, MODEL 100 (May 1, 2009)

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