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Hallux rigidus / Medical device / Premarket approval / Metatarsophalangeal articulations / Bone cement / Bunion / Arthroplasty / Federal Food / Drug / and Cosmetic Act / Center for Devices and Radiological Health / Medicine / Food and Drug Administration / Orthopedic surgery


FES[removed]k) Summary Summary of 510 (k) safety and -ttttvefess iformation upon which the substantial equivalence determination is based: Prepared:
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Document Date: 2012-03-26 00:31:57

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File Size: 124,85 KB

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City

Memphis / /

Company

Solana Surgical LLC / K120029 Trade / /

Currency

KWD / /

Event

FDA Phase / /

IndustryTerm

manufacturing practice requirements / cement / marketed predicate devices / manufacturing practice / announcements concerning your device / predicate devices / Internet address http /

Organization

Division of Postmarket Surveillance / office of DevX Evaluation / Food and Drug Administration / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Surgical / Orthopedic / and Restorative Devices Office / Center for Devices and Radiological Health / office of Compliance / CDRH's office of Surveillance / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / Division of Surgical / /

Person

Louise Focht / Silver Spring / Mark W Melkers / /

/

Position

Vice President Quality and Regulatory / Director / /

Product

Federal Food / /

ProvinceOrState

Maryland / Tennessee / /

Technology

radiation / /

URL

http /

SocialTag