Cleared Special

K061955 - RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS

K061955 is an FDA 510(k) clearance for RAYHACK LOW PROFILE LOCKING PLATE AND I..., manufactured by Creative Medical Designs, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 24-day FDA review.

K061955 · Creative Medical Designs, Inc. · Orthopedic device
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Aug 2006
Decision
24d
Days
Class 2
Risk

K061955 is an FDA 510(k) clearance for the RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Creative Medical Designs, Inc. (Tampa, US). The FDA issued a Cleared decision on August 4, 2006 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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.

View all Creative Medical Designs, Inc. devices

FDA 510(k) Submission Details - K061955

510(k) Number K061955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2006
Decision Date August 04, 2006
Days to Decision 24 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 1088
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K061955.
KLS MARTIN STERNAL TALON
K051165 · KLS-Martin L.P. · Sep 2006
DISTAL RADIUS LOCKING PLATING SYSTEM
K061917 · Newclip Technics · Aug 2006
SYNTHES (USA) CLAVICLE HOOK PLATES
K061753 · Synthes (Usa) · Aug 2006
LISFRANC PLATE
K060474 · New Deal, S.A. · Aug 2006
MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM
K053624 · Medicon EG · Jul 2006
CALCANEAL TRAUMA SYSTEM
K061400 · Orthohelix Surgical Designs, Inc. · Jun 2006