Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006493760

FEI Number

3006493760

Entity Name

ICOTEC AG

City/State/Country

Altstaetten Sankt Gallen, CH

Establishment Address

Industriestrasse 12, Altstaetten Sankt Gallen 9450, CH

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

icotec ag (Owner Number: 10042564)

Owner / Operator Contact Address

Industriestrasse 12, Altstaetten, CH-SG 9450, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232628

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-11-03
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2020-10-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-10-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-01-10
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2023-01-10
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-06-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-06-15
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2020-06-03
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2020-06-03
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-04-09
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2025-11-15
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-11-15
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-12-15
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-03-03
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2025-03-03
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2024-07-26
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-07-26
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2024-07-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-07-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-07-26
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2024-07-26
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2024-07-26
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2024-07-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-07-26
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2024-07-26

Official Correspondent

Vanessa Faessler

US Agent Details

Ethan Naylor Business: MCRA, LLC Email: ethan.naylor@mcra.com Phone: (571) 3961248

Related Public Records

Same Entity

icotec 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006493760. Last updated year: 2026. Please use registration number 3006493760 when referencing this establishment in official correspondence.