METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET

Prosthesis, Toe, Hemi-, Phalangeal

SOLANA SURGICAL LLC

The following data is part of a premarket notification filed by Solana Surgical Llc with the FDA for Metatarsal Decompression Implant Surgical Instrument Set.

Pre-market Notification Details

Device IDK113752
510k NumberK113752
Device Name:METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET
ClassificationProsthesis, Toe, Hemi-, Phalangeal
Applicant SOLANA SURGICAL LLC 6363 POPLAR AVE SUITE 434 Memphis,  TN  38119
ContactLouise Focht
CorrespondentLouise Focht
SOLANA SURGICAL LLC 6363 POPLAR AVE SUITE 434 Memphis,  TN  38119
Product CodeKWD  
CFR Regulation Number888.3730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-21
Decision Date2012-02-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420173201 K113752 000
00840420173195 K113752 000
00840420173188 K113752 000
00840420173171 K113752 000

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