FDA.report

OptumSI Implant System

Primary DI
00850057247121
Brand
OptumSI Implant System
Company
SI Solutions, LLC
Model
12-00030
Device description
Adjustable Stop
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OURSacroiliac Joint Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions

SubmissionSupplement
K251365000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K251365000OptumSI Implant SystemSi Solutions, LLC2025-11-20OUR

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850057247121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057247121008500572471218500572471210850057247121

GMDN Terms

TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implantation kitA collection of 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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
120155935
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850057247008OptumSI Implant System11-115302025-12-16
00850057247015OptumSI Implant System12-000012025-12-16
00850057247022OptumSI Implant System12-000022025-12-16
00850057247039OptumSI Implant System12-000032025-12-16
00850057247046OptumSI Implant System12-000042025-12-16
00850057247053OptumSI Implant System12-000052025-12-16
00850057247060OptumSI Implant System12-000102025-12-16
00850057247077OptumSI Implant System12-000112025-12-16
00850057247084OptumSI Implant System12-000172025-12-16
00850057247091OptumSI Implant System12-000212025-12-16
00850057247107OptumSI Implant System12-000262025-12-16
00850057247114OptumSI Implant System12-000272025-12-16
00850057247138OptumSI Implant System12-000352025-12-16
00850057247145OptumSI Implant System12-000372025-12-16
00850057247152OptumSI Implant System12-000402025-12-16
00850057247169OptumSI Implant System12-000412025-12-16
00850057247176OptumSI Implant System12-000422025-12-16
00850057247183OptumSI Implant System11-115352025-12-16
00850057247190OptumSI Implant System11-115402025-12-16
00850057247206OptumSI Implant System11-115452025-12-16

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