Cleared Traditional

K091134 - CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE

K091134 is an FDA 510(k) clearance for CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE, manufactured by Custom Spine, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K091134 · Custom Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
119d
Days
Class 2
Risk

K091134 is an FDA 510(k) clearance for the CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Custom Spine, Inc. (Parsippany, US). The FDA issued a Cleared decision on August 17, 2009 after a review of 119 days - within the typical 510(k) review window.

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 Custom Spine, Inc. devices

FDA 510(k) Submission Details - K091134

510(k) Number K091134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2009
Decision Date August 17, 2009
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
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 491
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K091134.
CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
K091926 · Choicespine, LP · Dec 2009
SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25
K092659 · Spinal USA · Nov 2009
XTEND ANTERIOR CERVICAL PLATE SYSTEM
K092146 · Globus Medical, Inc. · Nov 2009
TRUSS THORACOLUMBAR PLATE SYSTEM
K092108 · Globus Medical, Inc. · Aug 2009
SYNTHES ORACLE PLATE
K091159 · Synthes Spine · Jul 2009
SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM
K091044 · Spinal USA · Jul 2009