Cleared Traditional

K103838 - FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM

K103838 is an FDA 510(k) clearance for FIXED VARIABLE & CORPECTOMY CERVICAL PL..., manufactured by Precision Surgery , Ltd.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K103838 · Precision Surgery , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
47d
Days
Class 2
Risk

K103838 is an FDA 510(k) clearance for the FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Precision Surgery , Ltd. (Chesterland, US). The FDA issued a Cleared decision on February 15, 2011 after a review of 47 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 Precision Surgery , Ltd. devices

FDA 510(k) Submission Details - K103838

510(k) Number K103838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2010
Decision Date February 15, 2011
Days to Decision 47 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 122d · This submission: 47d
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 506
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K103838.
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APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
K102820 · Alphatec Spine, Inc. · Nov 2010