Cleared Traditional

K983260 - MODIFICATION TO SPINAL CONCEPTS BACFIX ...

K983260 is the FDA 510(k) clearance for MODIFICATION TO SPINAL CONCEPTS BACFIX ... by Spinal Concepts, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K983260 · Spinal Concepts, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
35d
Days
Class 2
Risk

K983260 is an FDA 510(k) clearance for the MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Spinal Concepts, Inc. (Austin, US). The FDA issued a Cleared decision on October 21, 1998 after a review of 35 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spinal Concepts, Inc. devices

Submission Details

510(k) Number K983260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1998
Decision Date October 21, 1998
Days to Decision 35 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K983260.
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
K982987 · Synthes Spine · Oct 1998
TSRH SPINAL SYSTEM
K982990 · Sofamor Danek USA,Inc. · Oct 1998
MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM
K983258 · Spinal Concepts, Inc. · Oct 1998
AESCULAP SPINE SYSTEM EVOLUTION
K980484 · Aesculap, Inc. · Oct 1998
AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS
K982914 · Aesculap, Inc. · Oct 1998
MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM
K982686 · Sofamor Danek USA,Inc. · Aug 1998