Cleared Traditional

K914966 - TSRH CENTRAL POST HOOKS

K914966 is an FDA 510(k) clearance for TSRH CENTRAL POST HOOKS, manufactured by Sofamor Danek Mfg., Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K914966 · Sofamor Danek Mfg., Inc. · Orthopedic device
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May 1992
Decision
189d
Days
Class 2
Risk

K914966 is an FDA 510(k) clearance for the TSRH CENTRAL POST HOOKS. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Sofamor Danek Mfg., Inc. (Memphis, US). The FDA issued a Cleared decision on May 12, 1992 after a review of 189 days - an extended review 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: 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 Sofamor Danek Mfg., Inc. devices

FDA 510(k) Submission Details - K914966

510(k) Number K914966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1991
Decision Date May 12, 1992
Days to Decision 189 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 122d · This submission: 189d
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 314
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K914966.
ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION
K920392 · Acromed Corp. · Dec 1992
ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR
K921090 · Acromed Corp. · Dec 1992
MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS
K912837 · Kirschner Medical Corp. · Aug 1992
CROSSLINK SYSTEM
K911663 · Synthes (Usa) · Mar 1992
TSRH VARIABLE ANGLE SACRAL SCREW
K904243 · Danek Medical, Inc. · Jan 1992
LUQUE SEGMENTAL SPINAL INSTRUMENTATION
K913561 · Zimmer, Inc. · Jan 1992