Cleared Traditional

MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM

K072251 · Merete Medical GmbH · Orthopedic
May 2008
Decision
269d
Days
—
Risk

About This 510(k) Submission

K072251 is an FDA 510(k) clearance for the MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM, a Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained, submitted by Merete Medical GmbH (Rye, US). The FDA issued a Cleared decision on May 8, 2008, 269 days after receiving the submission on August 13, 2007. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K072251 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2007
Decision Date May 08, 2008
Days to Decision 269 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LZJ — Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained
Device Class —

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