Cleared Traditional

K880215 - TSRH H/M HOOK

K880215 is an FDA 510(k) clearance for TSRH H/M HOOK, manufactured by Warsaw Orthopedic, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K880215 · Warsaw Orthopedic, Inc. · Orthopedic device
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Feb 1988
Decision
30d
Days
Class 2
Risk

K880215 is an FDA 510(k) clearance for the TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Warsaw Orthopedic, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 18, 1988 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Warsaw Orthopedic, Inc. devices

FDA 510(k) Submission Details - K880215

510(k) Number K880215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1988
Decision Date February 18, 1988
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K880215.
TSRH H/M HOOK HOLDER W/ROD MOVER
K880212 · Warsaw Orthopedic, Inc. · Mar 1988
ACROMED CROSS ROD CONNECTOR
K874882 · Acromed Corp. · Feb 1988
TSRH H/M TORQUE LIMITING WRENCH
K880214 · Warsaw Orthopedic, Inc. · Feb 1988
WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM
K870830 · Warsaw Orthopedic, Inc. · May 1987
KIRSCHNER SPINAL PRODUCT SYSTEM
K854524 · Kirschner Medical Corp. · Dec 1985
EDWARDS SACRAL SCREW
K851935 · Zimmer, Inc. · Jun 1985