Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614438

FEI Number

3010871687

Entity Name

SPHINX TOOLS LTD

City/State/Country

Derendingen Solothurn, CH

Establishment Address

Gewerbestrasse 1, Derendingen Solothurn 4552, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Sphinx Tools Ltd (Owner Number: 10028077)

Owner / Operator Contact Address

Gewerbestrasse 1, Derendingen, CH-SO 4552, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fairfax FibreKor SYNTHES Zimmer GMBH MEDARTIS INC. INTEGRA YORK PA INC. SYNTHES CMF MEDICON SURGICAL SYNTHES SYNTHES 9613350 CMF Medicon Surgical Inc Zimmer GMBH SYNTHES SYNTHES SYNTHES SYNTHES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2016-02-19
EJL	Bur, Dental	Dental	Class 1	872.3240	2008-12-29
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2008-12-29
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-01-22
HWT	Template	Orthopedic	Class 1	888.4800	2017-04-19
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2017-04-19
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2017-04-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-11
JEY	Plate, Bone	Dental	Class 2	872.4760	2016-12-12
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-10-28
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-01-22
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2026-05-21
HWB	Extractor	Orthopedic	Class 1	888.4540	2017-04-19
HTO	Reamer	Orthopedic	Class 1	888.4540	2013-01-22

Official Correspondent

Manuel Kummer

US Agent Details

Alfred Lerch Business: confinis USA Inc. Email: usagent@confinis.com Phone: (910) 2289391

Related Public Records

Same Entity

Sphinx Tools Ltd

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
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

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-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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614438. Last updated year: 2026. Please use registration number 9614438 when referencing this establishment in official correspondence.