SAMAPLAST AG

FDA Device Registration & Listing · Sankt Margrethen Sankt Gallen, CH · Registration 3008793310

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
3008793310
FEI Number
3008793310
Entity Name
SAMAPLAST AG
City/State/Country
Sankt Margrethen Sankt Gallen, CH
Establishment Address
Neugruetstrasse 3, Sankt Margrethen Sankt Gallen 9430, CH
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SAMAPLAST AG (Owner Number: 10043822)
Owner / Operator Contact Address
Neugruetstrasse 3, Sankt Margrethen, CH-SG 9430, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
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
OWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2025-01-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-10-24
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2013-03-26
MOQ Battery, Replacement, Rechargeable General, Plastic Surgery Class 1 878.4820 2020-10-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-06-16
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2026-06-16
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2026-06-16
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2026-06-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-06-16
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-06-21
HTO Reamer Orthopedic Class 1 888.4540 2016-10-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-10-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-03-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-03-26
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-03-26
HWT Template Orthopedic Class 1 888.4800 2013-03-26
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2015-03-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-06-07
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-06-07

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

SAMAPLAST 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
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K030151 Hayes Medical, Inc. CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM 2003-04-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
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.

Similar Registrations

Registration Number Establishment Name Location
1417592 MEDLINE INDUSTRIES, LP - Northfield Northfield, IL, US
3002807315 SYNERGY HEALTH STERILISATION UK LTD Daventry Northamptonshire, GB
3007663067 Systagenix Wound Management Manufacturing Limited North Yorkshire, GB
8044102 XIROS LTD YEADON Leeds, GB
1220477 ISOMEDIX OPERATIONS INC. Northborough, MA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008793310. Last updated year: 2026. Please use registration number 3008793310 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.