Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022295665

FEI Number

3022295665

Entity Name

AMNOVIS BV

City/State/Country

Aarschot Flanders, BE

Establishment Address

Betekomsesteenweg 47C, Aarschot Flanders 3200, BE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Amnovis BV (Owner Number: 10087492)

Owner / Operator Contact Address

Betekomsesteenweg 47C, Aarschot, BE-VLG 3200, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

E3D-A Interbody System E3D-C Interbody System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2024-06-03
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-06-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-06-03
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-10-10
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-03-06
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-03-06
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2023-03-06
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2024-12-09
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2024-12-09

Official Correspondent

Mindy McCann

US Agent Details

Mindy McCann Business: Qserve Group US Inc. Email: usagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

Amnovis BV

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
K192492	Astura Medical, LLC	EL CAPITAN Anterior Lumber Interbody System	2020-04-21
K212498	Nexus Spine, LLC	Stable-L Standalone Lumbar Interbody System	2022-03-18
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

Similar Registrations

Registration Number	Establishment Name	Location
3009144915	NUVASIVE, INC.	Guaynabo, PR, US
3003935342	MACKAY MANUFACTURING, INC.	Spokane Valley, WA, US
1056553	REMINGTON MEDICAL, INC.	ALPHARETTA, GA, US
3016112537	MAINSTREAM MEDICAL DEVICES	Austin, TX, US
3017048829	LINEAR PRECISION, INC.	Florence, SC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022295665. Last updated year: 2026. Please use registration number 3022295665 when referencing this establishment in official correspondence.