Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006694268

FEI Number

3006694268

Entity Name

CREATEC GmbH & CO. KG

City/State/Country

FRIEDRICHSHAFEN Baden-Wurttemberg, DE

Establishment Address

ECKENERSTRASSE 65/6, FRIEDRICHSHAFEN Baden-Wurttemberg D-88046, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CREATEC LTD. & CO. KG (Owner Number: 9099162)

Owner / Operator Contact Address

ECKENERSTRASSE 65/6, --, FRIEDRICHSHAFEN, DE-NOTA D-88046, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

#AR-9097-30; Retrograde Targeting Guide

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-02-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-09-09
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-02-23
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-11-22
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-11-22
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2016-04-13
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2024-11-27
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-11-06
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2017-08-07
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2017-08-07
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2017-08-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-07-16
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-07-16
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-10-21
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-08-22
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-06-26
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-09-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-09-17
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-17
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-02-20
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2023-02-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-07-08
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-07-08
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-02-05
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-26
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-05-03
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2022-04-04
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-06-26
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-06-05
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-26
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2024-04-22
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2024-04-22
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2017-03-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-09-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-09-02
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-06-26
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-26
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2020-02-25
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2019-11-11
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-02-05
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2017-05-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-05-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-12-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-12-12
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-03-19

Official Correspondent

No official correspondent registered.

US Agent Details

Sarah Strassburger Email: cs-medical@createc.com Phone: (260) 4467411

Related Public Records

Same Entity

CREATEC LTD. & CO. KG

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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
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 3006694268. Last updated year: 2026. Please use registration number 3006694268 when referencing this establishment in official correspondence.