Cleared Traditional

K970955 - ACROMED ANTERIOR CERVICAL STABILIZATION...

K970955 is an FDA 510(k) clearance for ACROMED ANTERIOR CERVICAL STABILIZATION..., manufactured by Acromed Corp.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K970955 · Acromed Corp. · Orthopedic device
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Jun 1997
Decision
86d
Days
Class 2
Risk

K970955 is an FDA 510(k) clearance for the ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Acromed Corp. (Cleveland, US). The FDA issued a Cleared decision on June 11, 1997 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Acromed Corp. devices

FDA 510(k) Submission Details - K970955

510(k) Number K970955 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 17, 1997
Decision Date June 11, 1997
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K970955.
M-2 ANTERIOR PLATE SYSTEM
K972718 · Acromed Corp. · Oct 1997
SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)
K970048 · Synthes (Usa) · Aug 1997
DUAL ROD ANTERIOR FIXATOR SYSTEM
K963780 · Sofamor Danek USA,Inc. · Jul 1997
KANEDA SR ANTERIOR SPINAL SYSTEM
K971248 · Acromed Corp. · Jun 1997
EBI SPINELINK SYSTEM
K964797 · Electro-Biology, Inc. · May 1997
ACPII ANTERIOR CERVICAL PLATE SYSTEM
K970806 · Sofamor Danek USA,Inc. · May 1997