Cleared Traditional

K262149 - corra® cervical plating system

K262149 is an FDA 510(k) clearance for corra cervical plating system, manufactured by Carlsmed, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K262149 · Carlsmed, Inc. · Orthopedic device
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Sep 2026
Decision
91d
Days
Class 2
Risk

K262149 is an FDA 510(k) clearance for the corra® cervical plating system. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Carlsmed, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 24, 2026 after a review of 91 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 Carlsmed, Inc. devices

FDA 510(k) Submission Details - K262149

510(k) Number K262149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2026
Decision Date September 24, 2026
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 640
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K262149.
Palisades™ Buttress Plate System
K261309 · Bethesda Medical Devices, LLC · Jul 2026
ARIES Anterior Cervical Plate Systems
K252776 · ZheJiang Decans Medical Devices Co., Ltd. · May 2026
CastleLoc-P Anterior Cervical Plate System
K261112 · L & K Biomed Co., Ltd. · May 2026
corra™ cervical plating system
K260570 · Carlsmed, Inc. · Apr 2026
VyPlate™ Anterior Cervical Plate System
K260697 · Vy Spine, LLC · Mar 2026
ANTERIS Thoracolumbar Plate System
K260015 · SpineCraft · Mar 2026