Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024124172

FEI Number

3024124172

Entity Name

ORTHOFUNDAMENTALS, LLC

City/State/Country

Hudson, MA, US

Establishment Address

43 Broad St Ste B403, Hudson, MA 01749, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OrthoFundamentals, LLC (Owner Number: 10085945)

Owner / Operator Contact Address

43 Broad Street, B403, Hudson, MA 01749, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OrthoFundamentals Trellis SI Joint Fusion System And Accessories AlloGr8 Posterior Allograft System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2022-09-14
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-05-01

Official Correspondent

Matthew Palmer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OrthoFundamentals, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K213667	SI-BONE, Inc.	iFuse-TORQ® Implant System	2022-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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3010143171	AR FABRICATING	Georgetown, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024124172. Last updated year: 2026. Please use registration number 3024124172 when referencing this establishment in official correspondence.