FDA.report

Trellis SI Joint Fusion System

Primary DI
G204OFSI09350
Brand
Trellis SI Joint Fusion System
Company
Orthofundamentals, LLC
Model
OFSI0935
Device description
9mm x 35mm Trellis SI Joint Fusion Screw
Published
2024-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OURSacroiliac Joint Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions

SubmissionSupplement
K212962000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K212962000TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC2022-04-11OUR

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G204OFSI09350PrimaryHIBCC0

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length35Millimeter
Outer Diameter9Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
617-398-0317info@orthofundamentals.com

Regulatory Flags

DUNS number
118041137
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
G204OFSIANDG0Trellis SI Joint Fusion SystemOFSIANDG2025-05-07
G204OFSI16OF0Trellis SI Joint Fusion SystemOFSI16OF2024-12-11
G204OFSI20OF0Trellis SI Joint Fusion SystemOFSI20OF2024-12-11
G204OFSI24TP0Trellis SI Joint Fusion SystemOFSI24TP2024-12-11
G204OFSIALLO0AlloGr8 Posterior Allograft SystemOFSIALLO2024-12-11
G204OFSIINST0Trellis SI Joint Fusion SystemOFSIINST2024-12-11
G204OFSIPLIN0Trellis SI Joint Fusion SystemOFSIPLIN2024-12-11
G204OFSIREM0Trellis SI Joint Fusion SystemOFSIREM2024-12-11
G204OFSISPLY0Trellis SI Joint Fusion SystemOFSISPLY2024-12-11
G204OFSI09300Trellis SI Joint Fusion SystemOFSI09302024-07-15
G204OFSI09400Trellis SI Joint Fusion SystemOFSI09402024-07-15
G204OFSI09450Trellis SI Joint Fusion SystemOFSI09452024-07-15
G204OFSI09500Trellis SI Joint Fusion SystemOFSI09502024-07-15
G204OFSI09550Trellis SI Joint Fusion SystemOFSI09552024-07-15
G204OFSI09600Trellis SI Joint Fusion SystemOFSI09602024-07-15
G204OFSI09650Trellis SI Joint Fusion SystemOFSI09652024-07-15
G204OFSI09700Trellis SI Joint Fusion SystemOFSI09702024-07-15
G204OFSI11300Trellis SI Joint Fusion SystemOFSI11302024-07-15
G204OFSI1130FT0Trellis SI Joint Fusion SystemOFSI1130FT2024-07-15
G204OFSI11350Trellis SI Joint Fusion SystemOFSI11352024-07-15

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