AIRLOCK centrolock SP032012

GUDID 03700879511979

CENTROLOCK cortical screw Ø2 length 12

NOVASTEP

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Primary Device ID	03700879511979
NIH Device Record Key	3e202625-ee94-496d-ae5d-95c335a9df27
Commercial Distribution Status	In Commercial Distribution
Brand Name	AIRLOCK centrolock
Version Model Number	SP032012
Catalog Number	SP032012
Company DUNS	264255288
Company Name	NOVASTEP
Device Count	1
DM Exempt	true
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	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

Customer Support Contacts

Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com
Phone	+33299338650
Email	contact@novastep-ortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700879511979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192356

FDA Product Code

HRS	Plate, Fixation, Bone

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	2020-01-10
Device Publish Date	2020-01-02

On-Brand Devices [AIRLOCK centrolock]

03700879512532	Centrolock implant trial holder
03700879512525	Centrolock Lid
03700879512518	Centrolock Tray
03700879512501	Centrolock temporary fixation pin - Single use
03700879512464	Centrolock K-wires holder
03700879512457	Centrolock countersink
03700879512440	Centrolock depth gauge
03700879512341	Centrolock countersink Single use
03700879512334	Centrolock temporary fixation pin
03700879512327	CENTROLOCK cortical screw Ø2 length 24
03700879512310	Airlock Centrolock Locking screw Ø2,5 length 26
03700879512303	Airlock Centrolock Locking screw Ø2,5 length 24
03700879512044	Centrolock drill bit Ø1.8 Single use
03700879512037	Centrolock drill bit Ø1.5 Single use
03700879512020	CENTROLOCK cortical screw Ø2 length 22
03700879512013	CENTROLOCK cortical screw Ø2 length 20
03700879512006	CENTROLOCK cortical screw Ø2 length 18
03700879511993	CENTROLOCK cortical screw Ø2 length 16
03700879511986	CENTROLOCK cortical screw Ø2 length 14
03700879511979	CENTROLOCK cortical screw Ø2 length 12
03700879511962	Airlock Centrolock Locking screw Ø2,5 length 22
03700879511955	Airlock Centrolock Locking screw Ø2,5 length 20
03700879511948	Airlock Centrolock Locking screw Ø2,5 length 18
03700879511931	Airlock Centrolock Locking screw Ø2,5 length 16
03700879511924	Airlock Centrolock Locking screw Ø2,5 length 14
03700879511917	Airlock Centrolock Locking screw Ø2,5 length 12
03700879511900	Airlock Centrolock Locking screw Ø2,5 length 10
03700879511894	Airlock Centrolock Locking screw Ø2,5 length 8
03700879511887	CENTROLOCK implant - Right step 6mm
03700879511870	CENTROLOCK implant - Right step 4mm
03700879511863	CENTROLOCK implant - Right step 2mm
03700879511856	CENTROLOCK implant - Left step 6mm
03700879511849	CENTROLOCK implant - Left step 4mm
03700879511832	CENTROLOCK implant - Left step 2mm
03700879511825	Centrolock trial implant - Right step 6mm
03700879511818	Centrolock trial implant - Right step 4mm
03700879511801	Centrolock trial implant - Right step 2mm
03700879511795	Centrolock trial implant - Left step 6mm
03700879511788	Centrolock trial implant - Left step 4mm
03700879511771	Centrolock trial implant - Left step 2mm
03700879511757	Centrolock impactor
03700879511740	Centrolock screwdriver tip T7
03700879511733	Centrolock drill bit Ø1.8
03700879511726	Centrolock drill bit Ø1.5
03700879511719	Centrolock drill guide - screw Ø2,5
03700879511702	Centrolock drill guide - screw Ø2
03700879511696	Centrolock targeting / compressing guide
03700879511689	Centrolock cannulated reamer
03700879511672	Centrolock elevator
03700879511665	Centrolock cutting guide