Cleared Traditional

K934007 - SOFAMOR ORFIL SPINE FIXATION SYSTEM

K934007 is an FDA 510(k) clearance for SOFAMOR ORFIL SPINE FIXATION SYSTEM, manufactured by Sofamor Co.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K934007 · Sofamor Co. · Orthopedic device
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Jun 1994
Decision
288d
Days
Class 2
Risk

K934007 is an FDA 510(k) clearance for the SOFAMOR ORFIL SPINE FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Sofamor Co. (France, FR). The FDA issued a Cleared decision on June 2, 1994 after a review of 288 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 Co. devices

FDA 510(k) Submission Details - K934007

510(k) Number K934007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1993
Decision Date June 02, 1994
Days to Decision 288 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
166d slower than avg
Panel avg: 122d · This submission: 288d
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 354
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K934007.
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K933881 · Depuy, Inc. · Jul 1994
ALPHA SPINAL SYSTEM
K930515 · Alphatec Mfg., Inc. · Jun 1994
TI-FRAME
K934860 · Johnson & Johnson Professionals, Inc. · Jun 1994
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