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Data / Medical devices / Germany / CREATEC GmbH & CO. KG

CREATEC GmbH & CO. KG: FDA-registered device maker in FRIEDRICHSHAFEN Baden-Wurttemberg, Germany, 15 510(k) clearances

CREATEC GmbH & CO. KG is registered with the FDA (registration 3006694268) in FRIEDRICHSHAFEN Baden-Wurttemberg, Germany. It lists 20 device types. The FDA files 15 510(k) clearances under its listings, the newest dated August 28, 2020. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch CREATEC GmbH & CO. KG
FDA registration number
3006694268
Address
Eckenerstrasse 65/6, FRIEDRICHSHAFEN Baden-Wurttemberg, Germany, D-88046
Owner or operator
CREATEC LTD. & CO. KG (9099162)
Roles
Contract manufacturer, Exporter to the US
First device listed
March 19, 2007
Registered through
2027
Brand names listed
#AR-9097-30; Retrograde Targeting Guide

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeLXT2Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Single ComponentKTW2Contract manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Component, Traction, InvasiveJEC2Contract manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Contract manufactureraccessdata.fda.gov
Knee Arthroplasty Implantation SystemOOG2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Nail, Fixation, BoneJDS2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Contract manufactureraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Contract manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Contract manufacturer, Exporter to the USaccessdata.fda.gov
RetractorGAD1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Support, Patient PositionCCX1Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 28, 2020K202099AOS Galileo™ Trochanteric Nail SystemHSBSubstantially EquivalentAdvanced Orthopaedic Solutions, Inc.accessdata.fda.gov
September 13, 2019K192217NCB Plating System Distal Femur and Proximal TibiaHRSSubstantially EquivalentZimmer GmbHaccessdata.fda.gov
July 18, 2019K191598AOS ES Retrograde Femoral NailHSBSubstantially EquivalentAdvanced Orthopaedic Solutions, Inc.accessdata.fda.gov
December 14, 2018K181827Affixus Natural Nail System Humeral NailHSBSubstantially EquivalentZimmer GmbHaccessdata.fda.gov
May 10, 2018K172583OrthoPediatrics PediNail Intramedullary PlatformHSBSubstantially EquivalentOrthopediatrics, Inc.accessdata.fda.gov
November 13, 2017K173166ANTHEM Fracture SystemHRSSubstantially EquivalentGlobus Medical, Inc.accessdata.fda.gov
May 22, 2017K170282Smith & Nephew VISIONAIRE Adaptive GuidesJWHSubstantially EquivalentSmith & Nephew, Inc.accessdata.fda.gov
September 18, 2014K141697XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEMKTTSubstantially EquivalentZimmer, Inc.accessdata.fda.gov
August 10, 2012K120715ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORTHSBSubstantially EquivalentZimmer GmbHaccessdata.fda.gov
June 26, 2012K113383XTRAFIX EXTERNAL FIXATION SYSTEMKTTSubstantially EquivalentExtraortho, Inc.accessdata.fda.gov
October 1, 2010K101622ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILSHSBSubstantially EquivalentZimmer, Inc.accessdata.fda.gov
April 12, 2010K100111NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEMHRSSubstantially EquivalentZimmer, Inc.accessdata.fda.gov
October 28, 2009K091566ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILSHSBSubstantially EquivalentZimmer GmbHaccessdata.fda.gov
February 19, 2009K083497ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILSHSBSubstantially EquivalentZimmer, Inc.accessdata.fda.gov
June 14, 2007K070444AOS TIBIAL NAILHSBSubstantially EquivalentAdvanced Orthopaedic Solutions, Inc.accessdata.fda.gov

Compare with other makers

Updated August 28, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.