Cleared Traditional

K903461 - TSRH OFFSET AND SIDE-LOADING HOOKS

K903461 is an FDA 510(k) clearance for TSRH OFFSET AND SIDE-LOADING HOOKS, manufactured by Danek Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K903461 · Danek Medical, Inc. · Orthopedic device
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Dec 1990
Decision
126d
Days
Class 2
Risk

K903461 is an FDA 510(k) clearance for the TSRH OFFSET AND SIDE-LOADING HOOKS. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on December 5, 1990 after a review of 126 days - within the typical 510(k) review window.

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: 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 Danek Medical, Inc. devices

FDA 510(k) Submission Details - K903461

510(k) Number K903461 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 01, 1990
Decision Date December 05, 1990
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
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 K903461.
ACROMED SACRAL SCREW
K903376 · Acromed Corp. · Dec 1990
TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)
K901005 · Danek Medical, Inc. · Dec 1990
KNIGHT SACRAL SCREW
K902775 · Danek Medical, Inc. · Dec 1990
TSRH SACRAL L-CONNECTOR
K901587 · Danek Medical, Inc. · Nov 1990
MODULOCK POSTERIOR SPINAL FIXATION
K902397 · Zimmer, Inc. · Nov 1990
DANEK SACRAL HOOK
K901590 · Danek Medical, Inc. · Aug 1990