GB IMPLANTAT TECHNOLOGIE GMBH

FDA Device Registration & Listing · Bochum North Rhine-Westphalia, DE · Registration 3000258338

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
3000258338
FEI Number
3000258338
Entity Name
GB IMPLANTAT TECHNOLOGIE GMBH
City/State/Country
Bochum North Rhine-Westphalia, DE
Establishment Address
Gesundheitscampus-Sud 5,, Bochum North Rhine-Westphalia 44801, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
gb Implantat Technologie GmbH (Owner Number: 10046279)
Owner / Operator Contact Address
Gesundheitscampus-Sud 5,, Bochum, DE-NW 45145, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Eclipse Implants CoCr Head -4, CoCr Head Neutral, CoCr Head +4, CoCr Head +8, CoCr Head +12 CoCr Head - Size 36, 40, 44 CoCr Head Neutral, CoCr Head +4, CoCr Head +8, CoCr Head -3.5, CoCr Head Neutral, CoCr Head +3.5, CoCr Head +7, CoCr Hea

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2014-02-27
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2014-02-27
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2019-08-14
QHQ Total Shoulder Arthroplasty System Orthopedic Class 2 888.3660 2019-08-14
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2014-02-27
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2014-02-27
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2014-09-02
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2014-09-02
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-05-01
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2017-11-07
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2017-11-07
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2017-11-07
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-05-01
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2017-11-03
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2014-02-27

Official Correspondent

Andreas Piotrowski

US Agent Details

Cherita James Business: Pro Pharma Group Email: cherita.james@propharmagroup.com Phone: (347) 9540624

Related Public Records

Same Entity

gb Implantat Technologie 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
K904879 Endotec, Inc. BEUCHEL-PAPPAS GLENOID COMPONENT 1991-01-28
K984202 Howmedica, Inc. HOWMEDICA HUMERAL INTERCALARY SYSTEM 1999-02-05
K141345 Tornier S.A.S. AEQUALIS FX2 2014-11-18
K030151 Hayes Medical, Inc. CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM 2003-04-10
K153381 Corin U.S.A. Limited Corin Metafix Hip Stem 2016-01-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.
Z-0027-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

Similar Registrations

Registration Number Establishment Name Location
3004983210 TORNIER Inc. Columbia City, IN, US
3013791180 OEB S.R.L. Camposanto Modena, IT
3009555447 Materialise Sdn Bhd Petaling Jaya Selangor, MY
3016851379 Arthrex Distribution Hub EMEA B.V. Venlo Limburg, NL
1424263 Isomedix Operations, Inc. Libertyville, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000258338. Last updated year: 2026. Please use registration number 3000258338 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.