DOT GMBH

FDA Device Registration & Listing · Rostock Mecklenburg-Western Pomerania, DE · Registration 3006001176

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
3006001176
FEI Number
3006001176
Entity Name
DOT GMBH
City/State/Country
Rostock Mecklenburg-Western Pomerania, DE
Establishment Address
Charles-Darwin-Ring 1a, Rostock Mecklenburg-Western Pomerania 18059, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
DOT GmbH (Owner Number: 10037690)
Owner / Operator Contact Address
Charles-Darwin-Ring 1a, Rostock, DE-MV 18059, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

EcoFit® short stem cementless EXODUS HIP STEM REMOVAL BLADES Z1 Hip Stem Z1 Hip Stem

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-11-26
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2025-12-12
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-12
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2025-12-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-03-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-03-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-03-07
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-18
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-03-26
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-18
JEY Plate, Bone Dental Class 2 872.4760 2013-01-18
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2020-08-12
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2020-08-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-18
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2020-08-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-03-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-03-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-01-16
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2026-03-27
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2015-01-12
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2024-11-26
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-06-26
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-06-26
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-18
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-01-18
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2013-01-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-18
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2024-11-26
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-11-26
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2024-11-26
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-11-26
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-09-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-01-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-01-16
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-18
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-09-10
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2011-08-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2011-08-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2011-08-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-01-16
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2016-06-07
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-01-18

Official Correspondent

Katrin Wenke

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

DOT 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
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
K140975 Lima Corporate S.P.A. MASTERSL FEMORAL STEM 2014-06-10
K932222 Dow Corning Wright SLT FEMORAL HEAD 1994-05-27
K910547 Turnkey Intergration USA, Inc. FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) 1991-04-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2023 Zimmer, Inc. 2
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006001176. Last updated year: 2026. Please use registration number 3006001176 when referencing this establishment in official correspondence.
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