Atrix-C Cervical Allograft Spacer

GUDID M697X09400231

Surgical instrument/implant rack

Primary Device ID	M697X09400231
NIH Device Record Key	b439fe1f-e3dc-4e77-9c8e-e77f5fc0c264
Commercial Distribution Status	In Commercial Distribution
Brand Name	Atrix-C Cervical Allograft Spacer
Version Model Number	X094-0023
Company DUNS	081224143
Company Name	Xtant Medical Holdings, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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 Issuing Agency	Device ID
HIBCC	M697X09400231 [Primary]

LRP	Tray, Surgical

Steralize Prior To Use	false
Device Is Sterile	false

M697X09400050	Sterilization Case Atrix-C Instruments
M697X09400030	Sterilization Case I, Atrix-C, Instruments
M697T09402000	Cortical Inserter Tip
M697T09400570	Forceps Inserter, Lateral Grasp
M697X09400231	ATRIX-C CORTICAL/CANCELLOUS IMPLANT SOFT CARRY CASE
M697X09400071	SOFT CARRY CASE II, ATRIX-C SPACERS
M697T09402001	Cortical Inserter Tip