RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)

Plate, Fixation, Bone

CREATIVE MEDICAL DESIGNS, INC.

The following data is part of a premarket notification filed by Creative Medical Designs, Inc. with the FDA for Rayhack Osteotomy System (modification).

Pre-market Notification Details

Device IDK952766
510k NumberK952766
Device Name:RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)
ClassificationPlate, Fixation, Bone
Applicant CREATIVE MEDICAL DESIGNS, INC. 13914 SHADY SHORES DR. Tampa,  FL  33613
ContactJohn M Rayhack
CorrespondentJohn M Rayhack
CREATIVE MEDICAL DESIGNS, INC. 13914 SHADY SHORES DR. Tampa,  FL  33613
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-31
Decision Date1995-12-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420143426 K952766 000
00840420143389 K952766 000

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