Threshold Pedicular Fixation System 530-0088

GUDID M7405300088

Orthopaedic prosthesis implantation positioning instrument, single-use

Primary Device ID	M7405300088
NIH Device Record Key	adc0b841-c102-45d6-95af-763270a7d857
Commercial Distribution Status	In Commercial Distribution
Brand Name	Threshold Pedicular Fixation System
Version Model Number	53-01-012
Catalog Number	530-0088
Company DUNS	033014361
Company Name	SPINEOLOGY INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
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 Issuing Agency	Device ID
HIBCC	M7405300088 [Primary]

LXH	Orthopedic Manual Surgical Instrument

Steralize Prior To Use	false
Device Is Sterile	true

M7405300097	Tower Wrench
M7405300096	Tower Socket
M7405300095	Fixed Jaws
M7405300094	Fixed Rod Holder
M7405300047	Distractor
M7405300046	Compressor
M7405300044	Open Counter Torque
M7405300043	Final Driver (S/N: )
M7405300040	Internal Rod Reducer
M7405300037	Set Screw Placer
M7405300036	Extension Reattachment
M7405300034	Counter Torque
M7405300033	Extension Pivot
M7405300031	External Reducer
M7405300016	Dilator Four
M7405300015	Dilator Three
M7405300014	Dilator Three (threaded)
M7405300013	Dilator Two
M7405300012	Dilator One
M7405300006	Cannulated Rod Pusher
M7405300005	AWL Handle
M7405300004	AWL Cap
M7405300003	AWL Stylet
M7405300002	Cannulated AWL Shaft
M7405500045	Rod Bender
M7405501500	Straight Rod
M7405501400	Straight Rod
M7405500200	Straight Rod
M7405500180	Straight Rod
M7405500160	Straight Rod
M7405500140	Straight Rod
M7405500120	Straight Rod
M7405500100	Straight Rod
M7405300041	Ratcheting Axial Handle
M7405300091	NiTi Guide Pin, 1.4mm x 610mm Blunt
M7405300090	NiTi Guide Pin, 1.4mm x 610mm Trocar/Round
M7405300089	Guide Pin, 1.4mm x 508mm Trocar/Round
M7405300088	Guide Pin, 1.4mm x 508mm Trocar/Round Threaded
M7405300087	Guide Pin, 1.4mm x 508mm Round/Round
M7405530043	In-Situ Bender
M7405530042	In-Situ Bender