GSELL MEDICAL PLASTICS AG

FDA Device Registration & Listing · Muri Aargau, CH · Registration 3006487372

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
3006487372
FEI Number
3006487372
Entity Name
GSELL MEDICAL PLASTICS AG
City/State/Country
Muri Aargau, CH
Establishment Address
Pilatusstrasse 32, Muri Aargau 5630, CH
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Gsell Medical Plastics AG (Owner Number: 10045374)
Owner / Operator Contact Address
Pilatusstrasse 32, Muri, CH-AG 5630, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Gating Reflector Block 5 PACK AFFIXUS

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 2021-04-01
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-06-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-03-10
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-10-26
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-03-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-03-10
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-03-13
GAD Retractor General, Plastic Surgery Class 1 878.4800 2015-03-26
HTD Forceps General, Plastic Surgery Class 1 878.4800 2017-05-02
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-03-10
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-11-11
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-06-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-06-28
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2024-06-28
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-05-14
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-03-10
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2023-05-01
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-07-11
HXD Clamp General, Plastic Surgery Class 1 878.4800 2019-10-31

Official Correspondent

Simon Gsell

US Agent Details

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

Related Public Records

Same Entity

Gsell Medical Plastics 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
K243523 Siemens Medical Solutions USA, Inc. NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime 2025-02-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2011 GE Medical Systems, LLC 2
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017 Philips Medical Systems 2
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017 Philips Medical Systems 2
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017 Philips Medical Systems 2
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017 Philips Medical Systems 2
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006487372. Last updated year: 2026. Please use registration number 3006487372 when referencing this establishment in official correspondence.
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