LEITNER AG

FDA Device Registration & Listing · Busswil Bern, CH · Registration 3009381600

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009381600
FEI Number
3009381600
Entity Name
LEITNER AG
City/State/Country
Busswil Bern, CH
Establishment Address
Amselweg 1, Busswil Bern 3292, CH
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Leitner AG (Owner Number: 10049857)
Owner / Operator Contact Address
Amselweg 1, Busswil, CH-BE 3292, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Bonebridge - Screwdriver 2.5mm Bonebridge - Screwdriver 3.5mm Smith-Nephew Trial Implants DepuySynthes Zimmer Biomet DepuySynthes Zimmer Biomet Bonebridge - Monoaxial Drill Guide Bonebridge - Insert Monoaxial Drill Guide Bonebridge - Exchangeable Bit 2.5mm Bonebridge - Exchangeable Bit 3.5mm (short 100mm) Bonebridge - Exchangeable Bit 3.5mm (long 180mm) Intervertebral Body Fusion Device Arthrex DepuySynthes

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 2019-07-11
HXX Screwdriver Orthopedic Class 1 888.4540 2024-07-04
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-12-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-12
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2016-01-27
NXT Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing Unknown Class 3 N/A 2016-12-01
HWT Template Orthopedic Class 1 888.4800 2025-05-28
HWB Extractor Orthopedic Class 1 888.4540 2017-02-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2022-03-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2022-12-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-08-30
HWJ Awl Orthopedic Class 1 888.4540 2018-03-27
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2017-02-20
HTW Bit, Drill Orthopedic Class 1 888.4540 2024-07-04
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-07-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-07-13
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2015-08-27
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2017-02-20

Official Correspondent

Ronnie Hirsbrunner

US Agent Details

Lance Johnson Business: LDJCG LLC Email: lance@ldjcg.com Phone: (512) 7757610

Related Public Records

Same Entity

Leitner 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
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
K161478 Xenco Medical, LLC Xenco Medical Posterior Cervical System 2016-09-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0013-05 Biomet, Inc. 2
Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009381600. Last updated year: 2026. Please use registration number 3009381600 when referencing this establishment in official correspondence.
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