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510(k) K090127

METATARSAL DECOMPRESSION IMPLANT, MODEL 100 by Solana Surgical, LLC — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2009
Date Received
January 21, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe, Hemi-, Phalangeal
Device Class
Class II
Regulation Number
888.3730
Review Panel
OR
Submission Type

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  • K113752 — METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET (February 6, 2012)
  • K120029 — HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET (February 6, 2012)

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