Cleared Traditional

K945064 - SELBY INSTRUMENTATION

K945064 is an FDA 510(k) clearance for SELBY INSTRUMENTATION, manufactured by Advanced Spine Fixation Systems, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K945064 · Advanced Spine Fixation Systems, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 1995
Decision
194d
Days
Class 2
Risk

K945064 is an FDA 510(k) clearance for the SELBY INSTRUMENTATION. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Advanced Spine Fixation Systems, Inc. (Cypress, US). The FDA issued a Cleared decision on April 26, 1995 after a review of 194 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 Advanced Spine Fixation Systems, Inc. devices

FDA 510(k) Submission Details - K945064

510(k) Number K945064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1994
Decision Date April 26, 1995
Days to Decision 194 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
72d slower than avg
Panel avg: 122d · This submission: 194d
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 208
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K945064.
ISOLA OPEN AND CLOSED SCREWS
K944756 · Acromed Corp. · May 1995
VSP (VARIABLE SCREW PLACEMENT)
K944736 · Acromed Corp. · May 1995
SELBY INSTRUMENTATION
K943775 · Advanced Spine Fixation Systems, Inc. · Apr 1995
SELBY INSTRUMENTATION
K942387 · Advanced Spine Fixation Systems, Inc. · Feb 1995
TSRH SPINAL SCREWS
K932029 · Sofamor Danek Mfg., Inc. · Jan 1995