Bio-composite Screw

GUDID 09348215122065

SIGNATURE ORTHOPAEDICS PTY LTD

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID09348215122065
NIH Device Record Keyc952a4db-3eb9-4b74-8c35-9da6faedd432
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio-composite Screw
Version Model Number121-05-6239
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS109348215122065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-14
Device Publish Date2023-08-04

On-Brand Devices [Bio-composite Screw ]

09348215116705121-05-2379
09348215116699121-05-2329
09348215116682121-05-1379
09348215116675121-05-1329
09348215116668121-05-0379
09348215116651121-05-0329
09348215116644121-05-9379
09348215116637121-05-9329
09348215116620121-05-9278
09348215116613121-05-9279
09348215116606121-05-8329
09348215116590121-05-8278
09348215116583121-05-8279
09348215029135121-05-8238
09348215029128121-05-8239
09348215029111121-05-7329
09348215029104121-05-7278
09348215122119121-05-7279
09348215122102121-05-7238
09348215122096121-05-7239
09348215122089121-05-6279
09348215122072121-05-6238
09348215122065121-05-6239
09348215122058121-05-5239
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.