Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013730328

FEI Number

3013730328

Entity Name

EIT EMERGING IMPLANT TECHNOLOGIES GMBH

City/State/Country

Wurmlingen Baden-Wurttemberg, DE

Establishment Address

Eisenbahnstrasse 84, Wurmlingen Baden-Wurttemberg 78573, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

EIT Emerging Implant Technologies GmbH (Owner Number: 10055063)

Owner / Operator Contact Address

Eisenbahnstrasse 84, Wurmlingen, DE-BW 78573, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172888

PMA Number

N/A

All Registered Proprietary Names

FSM trays EIT Cellular Titanium LLIF Cages EIT Cellular Titanium T/PLIF Cages EIT Cellular Titanium TLIF Cages EIT Cellular Titanium ALIF Cages EIT Cellular Titanium LLIF Cages EIT Cellular Titanium T/PLIF Cages EIT Cellular Titanium Cervical Cage LXH devices EIT Cellular Titanium Cervical Cage EIT Cellular Titanium ALIF Cages EIT Cellular Titanium TLIF Cages EIT Cellular Titanium PLIF Cages

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-12-06
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-11-23
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-12-12
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2020-10-23
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-10-23
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-08-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-05-15
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-05-15

Official Correspondent

Barbara Wirth

US Agent Details

Karen Parker Email: KPARKER2@its.jnj.com Phone: (610) 7196567

Related Public Records

Same Entity

EIT Emerging Implant Technologies 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
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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3012574325	HAKAMA AG	Baettwil Solothurn, CH
3001397320	ROECHLING MEDICAL ROCHESTER L.P.	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013730328. Last updated year: 2026. Please use registration number 3013730328 when referencing this establishment in official correspondence.