FDA.reportPublic FDA data

Integrity-SI Fusion System

Primary DI
B57112524401D0
Brand
Integrity-SI Fusion System
Company
Lincotek Medical LLC
Model
1252-4401
Catalog number
1252-4401
Device description
24mm Nav Sleeve
Published
2018-11-16
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B57112524401D0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implantation kitA collection of non-sterile surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117021487
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860794002679Versipass Suture Passer Needle472747272024-10-17
00860794002600Champion Suture Passer Ratchet Straight3910-900-0862024-01-02
00860794002617Champion Suture Passer Ratchet Humpback3910-900-0872024-01-02
00860794002624Champion Suture Passer Ratchet Straight Capture3910-900-0882024-01-02
00860794002631Champion Suture Passer Ratchet Humpback Capture3910-900-0892024-01-02
00860794002655Champion Suture Passer Needle3910-900-0912023-12-18
00860794002662Versipass Suture Passer47262023-12-12
B57112520006030D0Integrity-SI Fusion System1252-0006-0301252-0006-0302018-07-09
B57112520006035D0Integrity-SI Fusion System1252-0006-0351252-0006-0352018-07-09
B57112520006040D0Integrity-SI Fusion System1252-0006-0401252-0006-0402018-07-09
B57112520006045D0Integrity-SI Fusion System1252-0006-0451252-0006-0452018-07-09
B57112520006050D0Integrity-SI Fusion System1252-0006-0501252-0006-0502018-07-09
B57112520006055D0Integrity-SI Fusion System1252-0006-0551252-0006-0552018-07-09
B57112520006060D0Integrity-SI Fusion System1252-0006-0601252-0006-0602018-07-09
B57112520006065D0Integrity-SI Fusion System1252-0006-0651252-0006-0652018-07-09
B57112520006070D0Integrity-SI Fusion System1252-0006-0701252-0006-0702018-07-09
B57112521010040D0Integrity-SI Fusion System1252-1010-0401252-1010-0402018-07-09
B57112521010041D0Integrity-SI Fusion System1252-1010-0411252-1010-0412018-07-09
B57112521010045D0Integrity-SI Fusion System1252-1010-0451252-1010-0452018-07-09
B57112521010046D0Integrity-SI Fusion System1252-1010-0461252-1010-0462018-07-09

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Primary DI, Brand, Company table
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