Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005827567

FEI Number

3005827567

Entity Name

RUETSCHI TECHNOLOGY AG

City/State/Country

Muntelier Fribourg, CH

Establishment Address

Fabrikstrasse 35, Muntelier Fribourg 3286, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ruetschi Technology AG (Owner Number: 10043785)

Owner / Operator Contact Address

Fabrikstrasse 35, Muntelier, CH-FR 3286, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NEO Pedicle Screw System APTUS Wrist 2.5 System Neo Pedicle Screw System APTUS K-Wire System APTUS Cannulated Compression Screws APTUS headed Cannulated Compression Screws T-Handle Kit Removal Kit Compressor Distractor Kit Pedicle Screw Instrument Kit K-wire Kit Rod bender NEO Cage System NEO Cage System PALAMIX Cement Gun Cement Pusher NEO Pedicle Screw System Steffee Tap kit for Neo Pedicle Screw System APTUS Ankle Trauma System 2.8/3.5 Neo Pedicle Screw System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2022-11-16
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-11-16
HXG	Tamp	Orthopedic	Class 1	888.4540	2018-09-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-05-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-05-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-05-07
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2024-08-19
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-05-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-11-10
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-11-10
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-11-10
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2018-05-07
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2022-11-16
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2024-03-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-11-16
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-11-16
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2020-03-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-11-16
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2022-11-16
HXB	Probe	Orthopedic	Class 1	888.4540	2022-11-16
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2018-05-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-05-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-05-25
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2018-05-07

Official Correspondent

Adrian Hofer

US Agent Details

JODIE GILMORE Business: ONYX MEDICAL CORPORATION Email: jodie.gilmore@elosmedtech.com Phone: (901) 3236699

Related Public Records

Same Entity

Ruetschi Technology AG

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
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09
K160980	Spineology, Inc.	Threshold Pedicular Fixation System, Palisade Pedicular Fixation System	2016-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

Similar Registrations

Registration Number	Establishment Name	Location
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2648623	STERIS ISOMEDIX PUERTO RICO, INC.	Alts De Cerro Gordo 3&4, PR, US
3015309643	Merit Medical UK Limited	Earley Reading, GB
3008572623	ELMDOWN SRL UNIPERSONALE	milano Lombardy, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005827567. Last updated year: 2026. Please use registration number 3005827567 when referencing this establishment in official correspondence.