Cleared Traditional

K132594 - CROSSCHECK PLATING SYSTEM

K132594 is an FDA 510(k) clearance for CROSSCHECK PLATING SYSTEM, manufactured by Solana Surgical, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K132594 · Solana Surgical, LLC · Orthopedic device
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Dec 2013
Decision
116d
Days
Class 2
Risk

K132594 is an FDA 510(k) clearance for the CROSSCHECK PLATING SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Solana Surgical, LLC (Memphis, US). The FDA issued a Cleared decision on December 13, 2013 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Solana Surgical, LLC devices

FDA 510(k) Submission Details - K132594

510(k) Number K132594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2013
Decision Date December 13, 2013
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1046
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K132594.
LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE
K132787 · Aap Implantate AG · Dec 2013
ARIX HAND LOCKING SYSTEM
K132876 · Jeil Medical Corporation · Dec 2013
ZIMMER DISTAL RADIUS PLATING SYSTEM
K133246 · Zimmer, Inc. · Dec 2013
A.L.P.S. CALCANEAL PLATING SYSTEM
K132898 · Biomet Manufacturing Corp · Nov 2013
LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5
K131782 · Aap Implantate AG · Nov 2013
ARIX HAND SYSTEM
K131566 · Jeil Medical Corporation · Nov 2013