Cleared Traditional

K882525 - SPINAL MICROKNIFE (FDA 510(k) Clearance)

Class I Orthopedic device.

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

K882525 is an FDA 510(k) clearance for the SPINAL MICROKNIFE. Classified as Knife, Orthopedic (product code HTS), Class I - General Controls.

Submitted by Karlin Technology, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on September 22, 1988 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Karlin Technology, Inc. devices

Submission Details

510(k) Number K882525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1988
Decision Date September 22, 1988
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HTS Knife, Orthopedic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.