Cleared Traditional

K062181 - C-JAWS CERVICAL COMPRESSIVE MINI FRAME

K062181 is an FDA 510(k) clearance for C-JAWS CERVICAL COMPRESSIVE MINI FRAME, manufactured by Medicrea Technologies. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K062181 · Medicrea Technologies · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
169d
Days
Class 2
Risk

K062181 is an FDA 510(k) clearance for the C-JAWS CERVICAL COMPRESSIVE MINI FRAME. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medicrea Technologies (Round Rock, US). The FDA issued a Cleared decision on January 16, 2007 after a review of 169 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Medicrea Technologies devices

FDA 510(k) Submission Details - K062181

510(k) Number K062181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2006
Decision Date January 16, 2007
Days to Decision 169 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
47d slower than avg
Panel avg: 122d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 346
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K062181.
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K061579 · Medtronic Sofamor Danek · Aug 2006