Cleared Traditional

MEMORY METAL STAPLES, EASYCLIP

K122113 · Stryker Corp. · Orthopedic
Mar 2013
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K122113 is an FDA 510(k) clearance for the MEMORY METAL STAPLES, EASYCLIP, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Stryker Corp. (Malwah, US). The FDA issued a Cleared decision on March 12, 2013, 238 days after receiving the submission on July 17, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K122113 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2012
Decision Date March 12, 2013
Days to Decision 238 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDR — Staple, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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