Cleared Traditional

K964275 - ALPHA POSTERIOR SPINAL SYSTEM

K964275 is an FDA 510(k) clearance for ALPHA POSTERIOR SPINAL SYSTEM, manufactured by Sofamor Danek USA,Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K964275 · Sofamor Danek USA,Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
81d
Days
Class 2
Risk

K964275 is an FDA 510(k) clearance for the ALPHA POSTERIOR SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on January 14, 1997 after a review of 81 days - a notably fast clearance 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: 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 Sofamor Danek USA,Inc. devices

FDA 510(k) Submission Details - K964275

510(k) Number K964275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1996
Decision Date January 14, 1997
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
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 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K964275.
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K965145 · Depuy, Inc. · Mar 1997
TITANIUM CD HORIZON SPINAL SYSTEM
K962708 · Sofamor Danek USA,Inc. · Feb 1997
FINN ROD TO ROD CONNECTOR
K960444 · Smith & Nephew Richards, Inc. · Jan 1997
HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM
K962314 · Osteonics Corp. · Dec 1996
CD HORIZON SPINAL SYSTEM
K961633 · Sofamor Danek USA,Inc. · Dec 1996
ISOLA PEDIATRIC COMPONENTS
K962984 · Acromed Corp. · Nov 1996