MEDCARE SOLUTIONS GMBH

FDA Device Registration & Listing · Emmingen Baden-Wurttemberg, DE · Registration 3031240334

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
3031240334
FEI Number
3031240334
Entity Name
MEDCARE SOLUTIONS GMBH
City/State/Country
Emmingen Baden-Wurttemberg, DE
Establishment Address
In der Burg 2, Emmingen Baden-Wurttemberg D-78576, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
MedCare Solutions GmbH (Owner Number: 10092625)
Owner / Operator Contact Address
In der Burg 2, Emmingen, DE-BW D-78576, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-07-07
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2025-07-07
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2025-07-07
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2025-07-07
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2025-07-07
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2025-07-07
HWA Impactor Orthopedic Class 1 888.4540 2025-07-07
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-07-07
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2025-07-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-07-07
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2025-07-07
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2025-07-07
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-03-05
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-07-07
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-07-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-07-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-07-07
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-07-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-07-07
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2025-07-07
FDC Resectoscope, Working Element Gastroenterology, Urology Class 2 876.1500 2025-07-07
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2025-07-07
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2025-07-07
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2025-07-07
GAD Retractor General, Plastic Surgery Class 1 878.4800 2025-07-07
DWG Electrosurgical Device General, Plastic Surgery Class 2 878.4400 2025-07-07
HTT Burr, Orthopedic Orthopedic Class 1 888.4540 2025-03-05
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-07-07
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2025-07-07
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-07-07
HXL Mallet General, Plastic Surgery Class 1 878.4800 2025-07-07
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-07-07
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 2025-07-07
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2025-07-07
HTF Curette General, Plastic Surgery Class 1 878.4800 2025-07-07
HXC Wrench Orthopedic Class 1 888.4540 2025-07-07
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-07-07
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2025-07-07
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-07-07
HTD Forceps General, Plastic Surgery Class 1 878.4800 2025-07-07
HWN Instrument, Compression Orthopedic Class 1 888.4540 2025-07-07
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2025-07-07
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2025-07-07
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-07-07
EBL Pin, Retentive And Splinting, And Accessory Instruments Dental Class 1 872.3740 2025-07-07
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2025-07-07
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2025-03-05
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-07-07
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2025-07-07
HYA Forceps, Wire Holding General, Plastic Surgery Class 1 878.4800 2025-07-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-07-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-07-07
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2025-07-07
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-07-07
HXW Bender Orthopedic Class 1 888.4540 2025-07-07
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2025-07-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-07-07
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 2025-07-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-07-07
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-07-07
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-07-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-07-07
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-07-07
HTW Bit, Drill Orthopedic Class 1 888.4540 2025-01-29
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2025-07-07
HWX Tap, Bone Orthopedic Class 1 888.4540 2025-03-05
HAB Saw, Powered, And Accessories General, Plastic Surgery Class 1 878.4820 2025-07-07
FWF Camera, Television, Endoscopic, Without Audio General, Plastic Surgery Class 1 878.4160 2025-07-07
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2025-07-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-07-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-07-07
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2025-07-07
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2025-07-07
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2025-07-07
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2025-07-07
HTO Reamer Orthopedic Class 1 888.4540 2025-03-05

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: Business Support International Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

MedCare Solutions 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
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM 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-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031240334. Last updated year: 2026. Please use registration number 3031240334 when referencing this establishment in official correspondence.
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