Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015255331

FEI Number

3015255331

Entity Name

AMPLIFY SURGICAL

City/State/Country

Foothill Ranch, CA, US

Establishment Address

27092 Burbank, Foothill Ranch, CA 92610, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

amplify surgical (Owner Number: 10059198)

Owner / Operator Contact Address

27092 Burbank, Foothill Ranch, CA 92610, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192434

PMA Number

N/A

All Registered Proprietary Names

DualX DualX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-12-10
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-03-10

Official Correspondent

clark hutton

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

amplify surgical

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
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
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

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1526534	Sterigenics US, LLC	Lewis Center, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015255331. Last updated year: 2026. Please use registration number 3015255331 when referencing this establishment in official correspondence.