World Cup Size 62mm

GUDID 09348215065126

SIGNATURE ORTHOPAEDICS PTY LTD

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell
Primary Device ID09348215065126
NIH Device Record Key5e66e23e-c00b-4ef5-a666-30c46903e2dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Cup Size 62mm
Version Model Number111-49-5062
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
GS109348215065126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-15
Device Publish Date2021-03-07

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

09348215129224 - Verteloc Lumbar Cage 2024-03-20
09348215129231 - Verteloc Lumbar Cage 2024-03-20
09348215129248 - Verteloc Lumbar Cage 2024-03-20
09348215129255 - Verteloc Lumbar Cage 2024-03-20
09348215129262 - Verteloc Lumbar Cage 2024-03-20
09348215129279 - Verteloc Lumbar Cage 2024-03-20
09348215129286 - Verteloc Lumbar Cage 2024-03-20
09348215129293 - Verteloc Lumbar Cage 2024-03-20

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