SignaSure Cementless Cup

GUDID 09348215031015

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 Acetabular shell Acetabular shell

Primary Device ID	09348215031015
NIH Device Record Key	49233ad3-f541-464f-b385-fc32d1414d02
Commercial Distribution Status	In Commercial Distribution
Brand Name	SignaSure Cementless Cup
Version Model Number	111-27-0144
Company DUNS	751993028
Company Name	SIGNATURE ORTHOPAEDICS PTY LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348215031015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K211742

FDA Product Code

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

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-02-07
Device Publish Date	2022-01-28

On-Brand Devices [SignaSure Cementless Cup]

09348215031114	111-27-0164
09348215031107	111-27-0162
09348215031091	111-27-0160
09348215031084	111-27-0158
09348215031077	111-27-0156
09348215031060	111-27-0154
09348215031053	111-27-0152
09348215031046	111-27-0150
09348215031039	111-27-0148
09348215031022	111-27-0146
09348215031015	111-27-0144
09348215031008	111-27-0142