Fusion Ceramic Head 28mm

GUDID 09348215080914

SIGNATURE ORTHOPAEDICS PTY LTD

Ceramic femoral head prosthesis
Primary Device ID09348215080914
NIH Device Record Key873b3a3b-0295-415e-820f-7e9f436689bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameFusion Ceramic Head 28mm
Version Model Number111-22-0511
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
GS109348215080914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-23

On-Brand Devices [Fusion Ceramic Head 28mm]

09348215080914111-22-0511
09348215007836111-22-0511

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