Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

Primary DI
B74240308160
Brand
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
Company
TENON MEDICAL, INC.
Model
40308-16
Catalog number
40308-16
Device description
7.5mm Insertion Handle
Published
2020-06-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K180818000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180818000Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.2018-06-13OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B74240308160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterileA non-sterile 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter7.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117014636
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810204800005SImmetry SI Joint Fusion System 10-SL08540-0110-SL08540-012025-12-17
00810204800012SImmetry SI Joint Fusion System 10-SL08545-0010-SL08545-002025-12-17
00810204800029SImmetry SI Joint Fusion System 10-SL08550-0110-SL08550-012025-12-17
00810204800036SImmetry SI Joint Fusion System 10-SL08555-0110-SL08555-012025-12-17
00810204800043SImmetry SI Joint Fusion System 10-SL08560-0110-SL08560-012025-12-17
00810204800050SImmetry SI Joint Fusion System 10-SL08565-0110-SL08565-012025-12-17
00810204800067SImmetry SI Joint Fusion System 10-SL08570-0110-SL08570-012025-12-17
00810204800074SImmetry SI Joint Fusion System 10-SL08575-0110-SL08575-012025-12-17
00810204800081SImmetry SI Joint Fusion System 10-SL08580-012025-12-17
00810204800098SImmetry SI Joint Fusion System 10-SL08585-0110-SL08585-012025-12-17
00810204800104SImmetry SI Joint Fusion System 10-SL08590-0110-SL08590-012025-12-17
00810204800111SImmetry SI Joint Fusion System 10-SL08595-012025-12-17
00810204800128SImmetry SI Joint Fusion System 10-SL085100-0110-SL085100-012025-12-17
00810204800135SImmetry SI Joint Fusion System 10-SL085105-0110-SL085105-012025-12-17
00810204800142SImmetry SI Joint Fusion System 10-SL085110-0110-SL085110-012025-12-17
00810204800159SImmetry SI Joint Fusion System 10-SL10540-012025-12-17
00810204800166SImmetry SI Joint Fusion System 10-SL10545-0110-SL10545-012025-12-17
00810204800173SImmetry SI Joint Fusion System 10-SL10550-012025-12-17
00810204800180SImmetry SI Joint Fusion System 10-SL10555-0110-SL10555-012025-12-17
00810204800197SImmetry SI Joint Fusion System 10-SL10560-0110-SL10560-012025-12-17

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