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510(k) K120029

HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET by Solana Surgical, LLC — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2012
Date Received
January 4, 2012
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)
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