FDA.reportPublic FDA data

Blue Topaz Sacroiliac Screw System

Primary DI
B062300008560
Brand
Blue Topaz Sacroiliac Screw System
Company
Osseus Fusion Systems, LLC
Model
3000-08560
Catalog number
3000-08560
Device description
Sacroiliac Screw, 8.5x60mm, Blue Topaz
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213590000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213590000Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC2022-03-01OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B062300008560PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoatedAn implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.

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 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
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B06211000326Aries-TS TSLIF Lumbar Interbody System1100-0326S1100-0326S2022-11-04
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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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