C-Zero Pedicle Screw System

GUDID 09348215027957

SIGNATURE ORTHOPAEDICS PTY LTD

Spinal bone screw, non-bioabsorbable
Primary Device ID09348215027957
NIH Device Record Key3b9d3e52-185e-469a-ae30-b5321e7b8f51
Commercial Distribution StatusIn Commercial Distribution
Brand NameC-Zero Pedicle Screw System
Version Model Number131-32-1520
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
GS109348215027957 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-11-05
Device Publish Date2019-01-17

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

09348215027179 - Freedom Pedicle Screw System2024-11-07
09348215027186 - Freedom Pedicle Screw System2024-11-07
09348215027193 - Freedom Pedicle Screw System2024-11-07
09348215027209 - Freedom Pedicle Screw System2024-11-07
09348215027216 - Freedom Pedicle Screw System2024-11-07
09348215027223 - Freedom Pedicle Screw System2024-11-07
09348215027230 - Freedom Pedicle Screw System2024-11-07
09348215027247 - Freedom Pedicle Screw System2024-11-07

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