Cleared Traditional

K063275 - DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07)

K063275 is an FDA 510(k) clearance for DISTAL CLAVICULAR FRAGMENT IMMOBILIZATI..., manufactured by Terray Corp.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K063275 · Terray Corp. · Orthopedic device
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Jul 2007
Decision
270d
Days
Class 2
Risk

K063275 is an FDA 510(k) clearance for the DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Terray Corp. (Arnprior, CA). The FDA issued a Cleared decision on July 27, 2007 after a review of 270 days - an extended review cycle.

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 Terray Corp. devices

FDA 510(k) Submission Details - K063275

510(k) Number K063275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2006
Decision Date July 27, 2007
Days to Decision 270 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 122d · This submission: 270d
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 1076
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K063275.
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K071563 · Smith & Nephew, Inc. · Aug 2007
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K071549 · Small Bone Innovations, Inc. · Aug 2007
OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM
K071105 · Osteomed LP · Jul 2007
ACUMED CONGRUENT BONE PLATE SYSTEM
K071715 · Acumed, LLC · Jul 2007
SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE
K071264 · Synthes (Usa) · Jul 2007
SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM
K071184 · Synthes (Usa) · Jun 2007