FDA.report

Trellis SI Joint Fusion System

Primary DI
G204OFSIINST0
Brand
Trellis SI Joint Fusion System
Company
Orthofundamentals, LLC
Model
OFSIINST
Device description
Lateral SI Joint Fusion Instrument Kit
Published
2024-12-11
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
G204OFSIINST0PrimaryHIBCC0

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

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

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