RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS

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 Low Profile Locking Plate And Instruments.

Pre-market Notification Details

Device IDK061955
510k NumberK061955
Device Name:RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS
ClassificationPlate, Fixation, Bone
Applicant CREATIVE MEDICAL DESIGNS, INC. 13914 SHADY SHORES DR. Tampa,  FL  33613
ContactJane Rayhack
CorrespondentJane Rayhack
CREATIVE MEDICAL DESIGNS, INC. 13914 SHADY SHORES DR. Tampa,  FL  33613
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-11
Decision Date2006-08-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420143785 K061955 000
00840420143587 K061955 000
00840420143570 K061955 000
00840420143563 K061955 000
00840420143556 K061955 000
00840420143549 K061955 000
00840420143532 K061955 000
00840420143525 K061955 000
00840420143518 K061955 000
00840420143501 K061955 000
00840420143495 K061955 000
00840420143488 K061955 000
00840420143471 K061955 000
00840420143464 K061955 000
00840420143457 K061955 000
00840420143440 K061955 000
00840420143433 K061955 000
00840420143594 K061955 000
00840420143600 K061955 000
00840420143617 K061955 000
00840420143778 K061955 000
00840420143761 K061955 000
00840420143754 K061955 000
00840420143747 K061955 000
00840420143730 K061955 000
00840420143723 K061955 000
00840420143716 K061955 000
00840420143709 K061955 000
00840420143693 K061955 000
00840420143686 K061955 000
00840420143679 K061955 000
00840420143662 K061955 000
00840420143655 K061955 000
00840420143648 K061955 000
00840420143631 K061955 000
00840420143624 K061955 000
00840420143419 K061955 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.