Cleared Traditional

DAY STAPLE

K853267 · Protek, Inc. · Orthopedic
Sep 1985
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K853267 is an FDA 510(k) clearance for the DAY STAPLE, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 6, 1985, 32 days after receiving the submission on August 5, 1985. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K853267 FDA.gov
FDA Decision Cleared SN
Date Received August 05, 1985
Decision Date September 06, 1985
Days to Decision 32 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

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

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