Cleared Traditional

K924381 - PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS

K924381 is an FDA 510(k) clearance for PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS, manufactured by Cross Medical Products, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K924381 · Cross Medical Products, Inc. · Orthopedic device
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May 1993
Decision
260d
Days
Class 2
Risk

K924381 is an FDA 510(k) clearance for the PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Cross Medical Products, Inc. (Concord, US). The FDA issued a Cleared decision on May 18, 1993 after a review of 260 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 Cross Medical Products, Inc. devices

FDA 510(k) Submission Details - K924381

510(k) Number K924381 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 31, 1992
Decision Date May 18, 1993
Days to Decision 260 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 122d · This submission: 260d
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 368
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K924381.
LUQUE V SPINAL SYSTEM
K921256 · Sofamor Danek Mfg., Inc. · May 1993
ISOLA(R) TANDEM CONNECTOR
K922504 · Acromed Corp. · May 1993
AUGMENT POSTERIOR SPINAL FIXATION SYSTEM
K922672 · Sofamor Danek Mfg., Inc. · May 1993
TSRH CENTRAL POST HOOKS
K925811 · Sofamor Danek Mfg., Inc. · May 1993
PARAGON POSTERIOR SPINAL SYSTEM
K920546 · Sofamor Danek Mfg., Inc. · Jan 1993
ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION
K920392 · Acromed Corp. · Dec 1992