Home GUDID B0622109410
White Pearl Preferred Angle ACP
Primary DI B0622109410
Brand White Pearl Preferred Angle ACP
Company Osseus Fusion Systems, LLC
Model 2100-9410
Catalog number 2100-9410
Device description CERV SCREW, FIXED, SELF-TAPPING, 3.75x10mm, CORT/CANC, PREF ACP
Published 2017-01-11
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name KWQ Appliance, Fixation, Spinal Intervertebral Body
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B0622109410 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Metallic spinal interbody fusion cage A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 10 Millimeter Outer Diameter 3.75 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 933442068 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B06224200000 Black Diamond POCT 2420-0000 2420-0000 2023-06-14 B06224200001 Black Diamond POCT 2420-0001 2420-0001 2023-06-14 B06224200002 Black Diamond POCT 2420-0002 2420-0002 2023-06-14 B06211000524 Aries-TS TSLIF Lumbar Interbody System 1100-0524S 1100-0524S 2022-11-07 B06211000525 Aries-TS TSLIF Lumbar Interbody System 1100-0525S 1100-0525S 2022-11-07 B06211000526 Aries-TS TSLIF Lumbar Interbody System 1100-0526S 1100-0526S 2022-11-07 B06211000527 Aries-TS TSLIF Lumbar Interbody System 1100-0527S 1100-0527S 2022-11-07 B06211000528 Aries-TS TSLIF Lumbar Interbody System 1100-0528S 1100-0528S 2022-11-07 B06211000529 Aries-TS TSLIF Lumbar Interbody System 1100-0529S 1100-0529S 2022-11-07 B06211000126 Aries-TS TSLIF Lumbar Interbody System 1100-0126S 1100-0126S 2022-11-04 B06211000127 Aries-TS TSLIF Lumbar Interbody System 1100-0127S 1100-0127S 2022-11-04 B06211000128 Aries-TS TSLIF Lumbar Interbody System 1100-0128S 1100-0128S 2022-11-04 B06211000129 Aries-TS TSLIF Lumbar Interbody System 1100-0129S 1100-0129S 2022-11-04 B06211000326 Aries-TS TSLIF Lumbar Interbody System 1100-0326S 1100-0326S 2022-11-04 B06211000327 Aries-TS TSLIF Lumbar Interbody System 1100-0327S 1100-0327S 2022-11-04 B06211000328 Aries-TS TSLIF Lumbar Interbody System 1100-0328S 1100-0328S 2022-11-04 B06211000329 Aries-TS TSLIF Lumbar Interbody System 1100-0329S 1100-0329S 2022-11-04 B06211000520 Aries-TS TSLIF Lumbar Interbody System 1100-0520S 1100-0520S 2022-11-04 B06211000521 Aries-TS TSLIF Lumbar Interbody System 1100-0521S 1100-0521S 2022-11-04 B06211000522 Aries-TS TSLIF Lumbar Interbody System 1100-0522S 1100-0522S 2022-11-04
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