Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017065977

FEI Number

3017065977

Entity Name

NGMEDICAL GMBH

City/State/Country

Nonnweiler Saarland, DE

Establishment Address

Trierer Strasse 65, Nonnweiler Saarland 66620, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NGMedical GmbH (Owner Number: 10079411)

Owner / Operator Contact Address

Trierer Strasse 65, Nonnweiler, DE-SL 66620, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200429

PMA Number

N/A

All Registered Proprietary Names

BEE HA Extension BEE-short BEE PLIF BEE Cages

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	2026-01-03
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2024-05-02
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-06-09
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-02-10

Official Correspondent

Peter Weiland

US Agent Details

Christine Scifert Business: MRC Global, LLC Email: Christine.Scifert@askmrcglobal.com Phone: (901) 8318053

Related Public Records

Same Entity

NGMedical GmbH

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
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05

Similar Registrations

Registration Number	Establishment Name	Location
3021588295	XYRESIC LLC	Jackson, MI, US
3036496433	SPECTRUM SPINE INC	Jasper, GA, US
3027726367	HAPPE SPINE	Grand Rapids, MI, US
3027201862	XCIX DESIGN, LLC	Richmond, UT, US
3017936978	CARLSMED, INC.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017065977. Last updated year: 2026. Please use registration number 3017065977 when referencing this establishment in official correspondence.