Trial Cage 15deg 16M

GUDID 09348215066628

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

Primary Device ID	09348215066628
NIH Device Record Key	3d516a7d-3e14-4820-b048-a5c166c2635b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Trial Cage 15deg 16M
Version Model Number	135-15-0053
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	09348215066628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K163625

FDA Product Code

KWQ	Appliance, Fixation, Spinal Intervertebral Body