Cleared Traditional

K973687 - SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM

K973687 is an FDA 510(k) clearance for SPINAL CONCEPTS, manufactured by Spinal Concepts, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K973687 · Spinal Concepts, Inc. · Orthopedic device
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Mar 1998
Decision
173d
Days
Class 2
Risk

K973687 is an FDA 510(k) clearance for the SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Spinal Concepts, Inc. (Austin, US). The FDA issued a Cleared decision on March 18, 1998 after a review of 173 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Spinal Concepts, Inc. devices

FDA 510(k) Submission Details - K973687

510(k) Number K973687 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 26, 1997
Decision Date March 18, 1998
Days to Decision 173 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
51d slower than avg
Panel avg: 122d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 276
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K973687.
ACROMED TIMX PLATE BASED LOW BACK SYSTEM
K981274 · Acromed Corp. · Apr 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K980447 · DePuy Orthopaedics, Inc. · Apr 1998
WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER
K980496 · Wrightmedicaltechnologyinc · Apr 1998
SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS
K974749 · Cross Medical Products, Inc. · Mar 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974734 · United States Surgical, A Division of Tyco Healthc · Mar 1998
SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM
K973836 · Cross Medical Products, Inc. · Mar 1998