Centaur Pedicle Screw System

GUDID 09348215127060

SIGNATURE ORTHOPAEDICS PTY LTD

Trans-facet-screw internal spinal fixation system, sterile
Primary Device ID09348215127060
NIH Device Record Keyac9d3573-a969-4824-8824-91b7f9ac7b00
Commercial Distribution StatusIn Commercial Distribution
Brand NameCentaur Pedicle Screw System
Version Model Number131-08-2730
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215127060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-12
Device Publish Date2024-02-02

On-Brand Devices [Centaur Pedicle Screw System]

09348215127480131-08-6358
09348215127473131-08-6345
09348215127466131-08-6339
09348215127459131-08-6336
09348215127442131-08-6334
09348215127435131-08-6330
09348215127428131-08-6326
09348215127411131-08-5948
09348215127404131-08-5930
09348215127398131-08-5480
09348215127381131-08-5300
09348215127374131-08-5150
09348215127367131-08-5095
09348215127350131-08-5090
09348215127343131-08-5085
09348215127336131-08-5080
09348215127329131-08-5075
09348215127312131-08-5070
09348215127305131-08-5065
09348215127299131-08-5060
09348215127282131-08-5055
09348215127275131-08-5050
09348215127268131-08-5045
09348215127251131-08-5040
09348215127244131-08-5035
09348215127237131-08-5030
09348215127220131-08-4890
09348215127213131-08-4880
09348215127206131-08-4870
09348215127190131-08-4865
09348215127183131-08-4860
09348215127176131-08-4855
09348215127169131-08-4850
09348215127152131-08-4845
09348215127145131-08-4840
09348215127138131-08-4800
09348215127121131-08-2760
09348215127114131-08-2755
09348215127107131-08-2750
09348215127091131-08-2745
09348215127084131-08-2740
09348215127077131-08-2735
09348215127060131-08-2730
09348215127053131-08-2725
09348215127046131-08-2720
09348215127039131-08-2660
09348215127022131-08-2655
09348215127015131-08-2650
09348215127008131-08-2645
09348215126995131-08-2640

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