Cleared Special

K140645 - GIBRALT ROD-TO-ROD CROSS CONNECTORS

K140645 is an FDA 510(k) clearance for GIBRALT ROD-TO-ROD CROSS CONNECTORS, manufactured by Exactech Sarasota. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 29-day FDA review.

K140645 · Exactech Sarasota · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
29d
Days
Class 2
Risk

K140645 is an FDA 510(k) clearance for the GIBRALT ROD-TO-ROD CROSS CONNECTORS. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Exactech Sarasota (Sarasota, US). The FDA issued a Cleared decision on April 11, 2014 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K140645

510(k) Number K140645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2014
Decision Date April 11, 2014
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 412
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K140645.
CASPIAN SPINAL SYSTEM
K141284 · K2m, Inc. · Jul 2014
CASPIAN OCT SPINAL SYSTEM
K133288 · K2m, Inc. · Jul 2014
VIRAGE OCT SPINAL FIXATION SYSTEM
K133556 · Zimmer Spine, Inc. · Jun 2014
STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
K133374 · Pioneer Surgical Technology, Inc. (Rti Surgical, I · Mar 2014
BLACKBIRD SPINAL SYSTEM
K133214 · Choicespine, LP · Mar 2014
CENTURION POCT SYSTEM
K131833 · Orthofix, Inc. · Jan 2014