Cleared Traditional

K931208 - LOW PROFILE SLEAVE NUT ASSEMBLY

K931208 is an FDA 510(k) clearance for LOW PROFILE SLEAVE NUT ASSEMBLY, manufactured by Advanced Spine Fixation Systems, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 383-day FDA review.

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

FDA 510(k) Submission Details - K931208

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
Combination Product No
PCCP Authorized No
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.

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 353
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K931208.
TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON
K933205 · Danek Medical, Inc. · May 1994
LOW PROFILE MID CROSS BRACING
K931225 · Advanced Spine Fixation Systems, Inc. · May 1994
SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST
K930891 · Synthes (Usa) · Apr 1994
SENTRY POSTERIOR SPINAL SYSTEM
K930710 · Sofamor Danek Mfg., Inc. · Oct 1993
SELBY INSTRUMENTATION
K924474 · Advanced Spine Fixation Systems, Inc. · Sep 1993
COTREL - DUBOUSSET SPINE IMPLANTS
K921056 · Buckman Co., Inc. · Jun 1993