Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005032068

FEI Number

3005032068

Entity Name

SINTX Technologies Inc.

City/State/Country

Salt Lake City, UT, US

Establishment Address

1885 W 2100 S, Salt Lake City, UT 84119, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SINTX Technologies (Owner Number: 9071516)

Owner / Operator Contact Address

1885 W 2100 S, Salt Lake City, UT 84119, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SiNAPTIC Osteotomy Wedge System Valeo II Interbody Fusion Device System - Lumbar

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2026-01-06
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-01-02
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2015-01-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SINTX Technologies

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
K252254	Sinaptic Surgical	Osteotomy Wedge System	2025-10-17
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09

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3009540749	Medartis Inc.	Warsaw, IN, US
3003236702	MEDARTIS AG	BASEL Basel-Stadt, CH
3011301313	NVISION BIOMEDICAL TECHNOLOGIES, INC	San Antonio, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005032068. Last updated year: 2026. Please use registration number 3005032068 when referencing this establishment in official correspondence.