JOLINE GMBH & CO. KG

FDA Device Registration & Listing · HECHINGEN Baden-Wurttemberg, DE · Registration 3004734264

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004734264
FEI Number
3004734264
Entity Name
JOLINE GMBH & CO. KG
City/State/Country
HECHINGEN Baden-Wurttemberg, DE
Establishment Address
NEUE ROTTENBURGER STRASSE 50, HECHINGEN Baden-Wurttemberg D72379, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
JOLINE GMBH & CO. KG (Owner Number: 9106819)
Owner / Operator Contact Address
NEUE ROTTENBURGER STRASSE 50, --, HECHINGEN, DE-BW D72379, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Kyphoplasty System Allevo Mixer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRX Arthroscope Orthopedic Class 2 888.1100 2020-07-14
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2020-07-14
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2020-07-20

Official Correspondent

No official correspondent registered.

US Agent Details

Sammy K. SIlva Business: Joline Medical Inc. Email: ssilva@joline.us Phone: (978) 2458800

Related Public Records

Same Entity

JOLINE GMBH & CO. KG
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
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.

Similar Registrations

Registration Number Establishment Name Location
3044858680 JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD. Shanghai, CN
1650907 Isomedix Operations Inc. GRAND PRAIRIE, TX, US
3014615697 AMNOTEC INTERNATIONAL MEDICAL GMBH Neuhausen ob Eck Baden-Wurttemberg, DE
3043226252 ZAPALIGN LLC Fort Lauderdale, FL, US
3020978007 DONGGUAN BAO KANG DIAN ZI KE JI LIMITED Dongguan City Guangdong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004734264. Last updated year: 2026. Please use registration number 3004734264 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.