Cleared Traditional

CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY

K063370 · Arthrosurface, Inc. · Orthopedic
Jan 2007
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K063370 is an FDA 510(k) clearance for the CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY, a Prosthesis, Toe, Hemi-, Phalangeal (Class II — Special Controls, product code KWD), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on January 12, 2007, 65 days after receiving the submission on November 8, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3730.

Submission Details

510(k) Number K063370 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2006
Decision Date January 12, 2007
Days to Decision 65 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWD — Prosthesis, Toe, Hemi-, Phalangeal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3730

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