Cleared Traditional

LOW PROFILE SLEAVE NUT ASSEMBLY (K931208) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931208 · Advanced Spine Fixation Systems, Inc. · Orthopedic device
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Mar 1994
Decision
383d
Days
Class 2
Risk

K931208 is an FDA 510(k) clearance for the LOW PROFILE SLEAVE NUT ASSEMBLY. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Advanced Spine Fixation Systems, Inc. (Cypress, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 383 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Advanced Spine Fixation Systems, Inc. devices

Submission Details

510(k) Number K931208 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 10, 1993
Decision Date March 28, 1994
Days to Decision 383 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 122d · This submission: 383d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 99
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K931208.
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K933881 · Depuy, Inc. · Jul 1994
TI-FRAME
K934860 · Johnson & Johnson Professionals, Inc. · Jun 1994
SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST
K930891 · Synthes (Usa) · Apr 1994
SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST
K921948 · Synthes (Usa) · Jun 1993
CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT
K924142 · Codman & Shurtleff, Inc. · Jun 1993
CROSSLINK SYSTEM
K911663 · Synthes (Usa) · Mar 1992