TiLink InSite Disposable Kit

Primary DI
00810131882082
Brand
TiLink InSite Disposable Kit
Company
Surgentec, LLC
Model
SI-O-1000
Published
2026-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K243835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243835000TiLink-P SI Joint Fusion SystemSurGenTec, LLC2024-12-27OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810131882082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810131882082008101318820828101318820820810131882082

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

Regulatory Flags#

DUNS number
004095409
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00850040139587"SI Guidewire 9"""SR16-5001SI-P-GP2024-08-16
00810131880583 Mallet - Large - Large HeadSR99-60002024-12-10
00810131880590 Mallet - Large - Small HeadSR99-60012024-12-10
00810131880606"1/4"" Square Drill Chuck"SR99-60022024-12-10
00810131880729 Bone Chisel SR99-60032024-12-10
00858406007181OsteoFlo Synthetic NanoPutty Syringe- 1ccONP-S-012020-11-19
00858406007198OsteoFlo Synthetic NanoPutty Syringe- 2.5ccONP-S-022020-11-19
00858406007204OsteoFlo Synthetic NanoPutty Syringe- 510ccONP-S-102020-11-19
00858406007211OsteoFlo Synthetic NanoPutty Syringe- 5ccONP-S-052020-11-19
00858406007228OsteoFlo Synthetic NanoPutty Cartridge- 5ccONP-T-5002020-11-18
00858406007235OsteoFlo Synthetic NanoPutty Cartridge- 10ccONP-T-10002020-11-19
00081013188039 ION AO Coupling Cannulated Handle SR12-50062026-03-09
00810131880330"T-Handle 3/16"" Connection"SR11-50022026-03-09
00810131881252 6.5/7.0 Drill Bit SR12-64422026-03-09

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