Cleared Traditional

BONE SCREW

K893203 · Karlin Technology, Inc. · Orthopedic
Apr 1990
Decision
343d
Days
Class 2
Risk

About This 510(k) Submission

K893203 is an FDA 510(k) clearance for the BONE SCREW, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Karlin Technology, Inc. (Torrance, US). The FDA issued a Cleared decision on April 4, 1990, 343 days after receiving the submission on April 26, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K893203 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 1989
Decision Date April 04, 1990
Days to Decision 343 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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