FDA.reportPublic FDA data

AlloGr8 Posterior Allograft System

Primary DI
G204OFSIALLO0
Brand
AlloGr8 Posterior Allograft System
Company
Orthofundamentals, LLC
Model
OFSIALLO
Device description
Posterior Allograft 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
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G204OFSIALLO0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
617-398-0317info@orthofundamentals.com

Regulatory Flags#

DUNS number
118041137
Device count
1
Premarket exempt
true
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
G204OFSIANDG0Trellis SI Joint Fusion SystemOFSIANDG2025-05-07
G204OFSI16OF0Trellis SI Joint Fusion SystemOFSI16OF2024-12-11
G204OFSI20OF0Trellis SI Joint Fusion SystemOFSI20OF2024-12-11
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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00763000754747N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00822409082124N/AOrtho Development CorporationLXH2026-07-16
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00822409082148N/AOrtho Development CorporationLXH2026-07-16
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