Cleared Traditional

K081770 - BLACK WIDOW ANTERIOR BUTTRESS PLATE

K081770 is an FDA 510(k) clearance for BLACK WIDOW ANTERIOR BUTTRESS PLATE, manufactured by Omni Surgical, L.P.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K081770 · Omni Surgical, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
283d
Days
Class 2
Risk

K081770 is an FDA 510(k) clearance for the BLACK WIDOW ANTERIOR BUTTRESS PLATE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Omni Surgical, L.P. (Austin, US). The FDA issued a Cleared decision on April 2, 2009 after a review of 283 days - an extended review 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: 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 Omni Surgical, L.P. devices

FDA 510(k) Submission Details - K081770

510(k) Number K081770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2008
Decision Date April 02, 2009
Days to Decision 283 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
161d slower than avg
Panel avg: 122d · This submission: 283d
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 507
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K081770.
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