Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013961579

FEI Number

3013961579

Entity Name

ADDITIVE IMPLANTS

City/State/Country

Phoenix, AZ, US

Establishment Address

3101 E Shea Blvd Ste 122, Phoenix, AZ 85028, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Additive Implants, Inc. (Owner Number: 10052268)

Owner / Operator Contact Address

3101 East Shea Boulevard, Suite 122, Phoenix, AZ 85028, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211111

PMA Number

N/A

All Registered Proprietary Names

SureMAX-X SureMAX SureMAX-SA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2020-03-05
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2019-02-13
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2021-09-24

Official Correspondent

John Ehteshami

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Additive Implants, Inc.

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
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013961579. Last updated year: 2026. Please use registration number 3013961579 when referencing this establishment in official correspondence.