FDA.reportPublic FDA data

Trellis SI Joint Fusion System

Primary DI
G204OFSIANDG0
Brand
Trellis SI Joint Fusion System
Company
Orthofundamentals, LLC
Model
OFSIANDG
Device description
Angled Drill Guide
Published
2025-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212962000TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC2022-04-11OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G204OFSIANDG0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
6173062169info@orthofundamentals.com

Regulatory Flags#

DUNS number
118041137
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G204OFSI24TP0Trellis SI Joint Fusion SystemOFSI24TP2024-12-11
G204OFSISPLY0Trellis SI Joint Fusion SystemOFSISPLY2024-12-11
G204OFSI16OF0Trellis SI Joint Fusion SystemOFSI16OF2024-12-11
G204OFSI20OF0Trellis SI Joint Fusion SystemOFSI20OF2024-12-11
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
G204OFSI09300Trellis SI Joint Fusion SystemOFSI09302024-07-15
G204OFSI09350Trellis SI Joint Fusion SystemOFSI09352024-07-15
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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Primary DI, Brand, Company table
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00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
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00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
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00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
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00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
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