Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009380093

FEI Number

3009380093

Entity Name

TECTRI SA

City/State/Country

Court Bern, CH

Establishment Address

Route de Chaluet 17, Court Bern 2738, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TECTRI SA (Owner Number: 10045646)

Owner / Operator Contact Address

Route de Chaluet 17, Court, CH-BE 2738, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DePuy Synthes DePuy Synthes DePuy Synthes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-12-11
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-12-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-12-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-12-17

Official Correspondent

Jean-Pascal Wisard

US Agent Details

Douglas Robinson Business: Diener Precision Pumps Inc Email: drobinson@dpp.swiss Phone: (209) 3650405

Related Public Records

Same Entity

TECTRI SA

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
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05

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

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3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3009732568	BGS BETA-GAMMA-SERVICE GMBH & CO KG	Wiehl North Rhine-Westphalia, DE
1424263	Isomedix Operations, Inc.	Libertyville, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009380093. Last updated year: 2026. Please use registration number 3009380093 when referencing this establishment in official correspondence.