Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016668776

FEI Number

3016668776

Entity Name

AXIS SPINE TECHNOLOGIES LTD

City/State/Country

Leeds, GB

Establishment Address

Century Offices, 2175 Century Way, Thorpe Park, Leeds LS15 8ZB, GB

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Reprocess Single-Use Device,Complaint File Establishment per 21 CFR 820.198,Remanufacture Medical Device

Owner / Operator

Axis Spine Technologies Ltd (Owner Number: 10078787)

Owner / Operator Contact Address

Century Offices, 2175 Century Way, Thorpe Park, Leeds, GB-NOTA LS15 8ZB, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210590

PMA Number

N/A

All Registered Proprietary Names

AXIS ALIF IMPLANTS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-12-22

Official Correspondent

James Hewitt

US Agent Details

Hannah Taggart Business: Applied Technical Services Email: htaggart@atslab.com Phone: (719) 4571152

Related Public Records

Same Entity

Axis Spine Technologies Ltd

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016668776. Last updated year: 2026. Please use registration number 3016668776 when referencing this establishment in official correspondence.