FDA.reportPublic FDA data

White Pearl Preferred Angle ACP

Primary DI
B0622109514
Brand
White Pearl Preferred Angle ACP
Company
Osseus Fusion Systems, LLC
Model
2100-9514
Catalog number
2100-9514
Device description
CERV SCREW, VARIABLE, SELF-DRILLING, 4.25x14mm, 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160522000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160522000White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC2016-04-26KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0622109514PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA 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
TypeValueUnit
Length14Millimeter
Outer Diameter4.25Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-330-5960Info@osseus.com

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 DIBrandModelCatalogPublished
B06224200000Black Diamond POCT2420-00002420-00002023-06-14
B06224200001Black Diamond POCT2420-00012420-00012023-06-14
B06224200002Black Diamond POCT2420-00022420-00022023-06-14
B06211000524Aries-TS TSLIF Lumbar Interbody System1100-0524S1100-0524S2022-11-07
B06211000525Aries-TS TSLIF Lumbar Interbody System1100-0525S1100-0525S2022-11-07
B06211000526Aries-TS TSLIF Lumbar Interbody System1100-0526S1100-0526S2022-11-07
B06211000527Aries-TS TSLIF Lumbar Interbody System1100-0527S1100-0527S2022-11-07
B06211000528Aries-TS TSLIF Lumbar Interbody System1100-0528S1100-0528S2022-11-07
B06211000529Aries-TS TSLIF Lumbar Interbody System1100-0529S1100-0529S2022-11-07
B06211000126Aries-TS TSLIF Lumbar Interbody System1100-0126S1100-0126S2022-11-04
B06211000127Aries-TS TSLIF Lumbar Interbody System1100-0127S1100-0127S2022-11-04
B06211000128Aries-TS TSLIF Lumbar Interbody System1100-0128S1100-0128S2022-11-04
B06211000129Aries-TS TSLIF Lumbar Interbody System1100-0129S1100-0129S2022-11-04
B06211000326Aries-TS TSLIF Lumbar Interbody System1100-0326S1100-0326S2022-11-04
B06211000327Aries-TS TSLIF Lumbar Interbody System1100-0327S1100-0327S2022-11-04
B06211000328Aries-TS TSLIF Lumbar Interbody System1100-0328S1100-0328S2022-11-04
B06211000329Aries-TS TSLIF Lumbar Interbody System1100-0329S1100-0329S2022-11-04
B06211000520Aries-TS TSLIF Lumbar Interbody System1100-0520S1100-0520S2022-11-04
B06211000521Aries-TS TSLIF Lumbar Interbody System1100-0521S1100-0521S2022-11-04
B06211000522Aries-TS TSLIF Lumbar Interbody System1100-0522S1100-0522S2022-11-04

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