Cleared Traditional

K882525 - SPINAL MICROKNIFE

K882525 is an FDA 510(k) clearance for SPINAL MICROKNIFE, manufactured by Karlin Technology, Inc.. The device is a Class 1 Orthopedic device with product code HTS cleared through the Traditional 510(k) pathway after a 97-day FDA review.

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

FDA 510(k) Submission Details - K882525

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

HTS Device Classification - Class 1, General Controls

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.

Regulatory Peers - HTS Knife, Orthopedic

All 7
Devices cleared under the same product code (HTS) and FDA review panel - the closest regulatory comparables to K882525.
CUSTOM ORTHOPAEDIC TRAYS (PACKS)
K930507 · Associated Medical Products Co. · Feb 1994
ACUFLEX DISPOSABLE KNIVES
K933921 · Acufex Microsurgical, Inc. · Jan 1994
RETROGRADE KNIFE, DISPOSABLE #TM-1613
K873711 · Arthropedics, Inc. · Nov 1987
TRIANGULAR KNIFE, DISPOSABLE #TM-1611
K873713 · Arthropedics, Inc. · Nov 1987
BANANA KNIFE, DISPOSABLE #TM-1612
K873714 · Arthropedics, Inc. · Nov 1987
STANDARD KNIFE, DISPOSABLE #TM-1610
K873712 · Arthropedics, Inc. · Oct 1987