Origin Trial Neck

GUDID 09348215039790

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable

Primary Device ID	09348215039790
NIH Device Record Key	3cc64ec1-e64e-4097-aff9-85bbab837fe7
Commercial Distribution Status	In Commercial Distribution
Brand Name	Origin Trial Neck
Version Model Number	111-182-020
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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
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	09348215039790 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121297

FDA Product Code

HWT	Template
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LXH	Orthopedic Manual Surgical Instrument