Cleared Traditional

SPINAL MICROKNIFE

K882525 · Karlin Technology, Inc. · Orthopedic
Sep 1988
Decision
97d
Days
Class 1
Risk

About This 510(k) Submission

K882525 is an FDA 510(k) clearance for the SPINAL MICROKNIFE, a Knife, Orthopedic (Class I — General Controls, product code HTS), submitted by Karlin Technology, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on September 22, 1988, 97 days after receiving the submission on June 17, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K882525 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1988
Decision Date September 22, 1988
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code HTS — Knife, Orthopedic
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4540

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