MK medical GmbH

FDA Device Registration & Listing · Emmingen-Liptingen Baden-Wurttemberg, DE · Registration 3010673850

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
3010673850
FEI Number
3010673850
Entity Name
MK medical GmbH
City/State/Country
Emmingen-Liptingen Baden-Wurttemberg, DE
Establishment Address
Jahnstr. 14, Emmingen-Liptingen Baden-Wurttemberg 78576, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
MK medical (Owner Number: 10045972)
Owner / Operator Contact Address
Jahnstr. 14, Emmingen-Liptingen, DE-BW 78576, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

K-Wire cleaning wire Drill Wire K-wire Guide Wire Tube

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2022-12-23
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2023-03-16
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2018-02-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-11-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-11-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-11-17
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 2021-11-10
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2020-09-25
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2023-07-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-02-09
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2015-02-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-02-09
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2023-07-25
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2021-11-10
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-11-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-03-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-02-09
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2015-02-09
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2023-07-25
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2015-02-18
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2020-07-17
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2023-07-20
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2023-07-20

Official Correspondent

Michael Krix

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

MK medical
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
K895079 Buckman Co., Inc. ACE BEADED K-WIRES ACE OLIVE WIRES 1989-09-13
K922193 Osteo AG OSTEO KIRSCHNER WIRE 1992-07-23
K850026 Kirkstil Corp., Inc. ORTHOPEDIC IMPLANT NAILS & PINS 1985-05-20
K963367 Rms Div. RMS K-WIRE 1996-10-30
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-05 Biomet, Inc. 2
Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010673850. Last updated year: 2026. Please use registration number 3010673850 when referencing this establishment in official correspondence.
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