SYMMETRY MEDICAL POLYVAC SAS

FDA Device Registration & Listing · WAMBRECHIES Nord, FR · Registration 3008534770

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
3008534770
FEI Number
3008534770
Entity Name
SYMMETRY MEDICAL POLYVAC SAS
City/State/Country
WAMBRECHIES Nord, FR
Establishment Address
Parc d activites du moulin, 139 Avenue Clement Ader, WAMBRECHIES Nord 59118, FR
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Symmetry Medical Polyvac SAS (Owner Number: 10042509)
Owner / Operator Contact Address
Parc d'activites du moulin, 139 Avenue Clement Ader, WAMBRECHIES, FR-59 59118, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NeuroNav Astra Tech Implant System Ultrasonic cleaning cassette TiLobeMAXX™ Surgical Kit I-HEXMRT Surgical Kit Piccolo Composite Nailing System Minimally Invasive Deformity Correction (MID-C) System CarboClear X Pedicle Screw System CarboClear Hybrid Pedicle Screw System CarboClear X Pedicle Screw System Neuro Omega Piccolo Composite Plate System SDS Surgical Tray Surgical Tray TiLobeMAXX™/I-HEXMRT TRUE/LOK SYSTEM Blue Mountain Cervical Plate System CarboClear Anterior Cervical Systems - Cervical Palte, Cervical Cage, Cervical VBR ARROW Piccolo Composite Plate System Piccolo Composite Nailing System PACK PIEZOTOME 2 ROI-C Straumann Modular Cassette KIT INTERNA/KIT VEGA/KIT ESSENTIAL Instrument Case Twin Peaks Lumbar Interbody Fusion System CENTRONAIL TITANIUM TIBIAL NAILING SYSTEM CENTRONAIL TITANIUM UNIVERSAL FEMORAL NAILING SYSTEM CENTRONAIL TITANIUM HUMERAL NAILING SYSTEM CENTRONAIL TITANIUM SUPRACONDYLAR NAILING SYSTEM TITANUM TROCHANTERIC NAILING SYSTEM CarboClear Hybrid Pedicle Screw System CarboClear Pedicle Screw System TELEGRAPH LUXOR GALAXY FIXATION SYSTEM TELEGRAPH Caliper Piccolo Composite Nailing System CarboClear Lumbar Cage System Piccolo Composite Plate System Piccolo Composite Nailing System Leksell Vantage Arc Tray Inion FreedomScrewTMInstrument tray Inion FreedomPinTM Instrument tray X-Twist Mini Sterilization Tray Shoulder Arthroscopy Set Osteotec Piccolo Composite Plate System Universal Clamp HYBRID FIXATOR ASSEMBLY SHEFFIELD RING FIXATOR ARROW KHEIRON Piccolo Composite Nailing System Piccolo Composite Plate System Piccolo Composite Nailing System Sterilization Tray for Multipurpose Arc Sterilizing Tray Sterilization Tray Frame Fixation Frame G Sterilization Tray Sterilization tray Small Sterilization Tray Needle tester CarboClear X Pedicle Screw System Piccolo Composite Plate System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GZL Electrode, Depth Neurology Class 2 882.1330 2022-01-07
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2013-02-28
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-01-17
QGP Posterior Ratcheting Rod System Unknown Class N N/A 2020-09-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-15
GZL Electrode, Depth Neurology Class 2 882.1330 2022-01-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-06-17
OFY Dental Implant Surgical Tray Dental Class 1 872.3980 2024-09-24
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2014-02-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-01-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-06-17
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-12-24
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2021-12-24
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-12-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-06-17
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-06-17
HXX Screwdriver Orthopedic Class 1 888.4540 2016-10-28
DZI Drill, Bone, Powered Dental Class 2 872.4120 2024-09-23
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2013-02-28
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2023-12-13
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2023-04-11
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2023-04-13
GAD Retractor General, Plastic Surgery Class 1 878.4800 2013-02-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-06-14
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2014-02-07
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-02-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-06-17
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-12-24
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2013-02-27
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2014-02-07
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2022-01-13
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-12-24
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2024-09-24
KTZ Caliper Orthopedic Class 1 888.4150 2017-01-24
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2024-09-24
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-06-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-06-17
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2021-06-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-06-17
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-06-17
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-06-17
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-17
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2024-09-24
OJH Orthopedic Tray General, Plastic Surgery Class 1 878.4800 2024-07-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-06-17
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-06-17
HTD Forceps General, Plastic Surgery Class 1 878.4800 2016-10-28
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2014-02-07
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-12-24
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-12-24
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-12-24
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2024-09-24
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-06-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-04-15
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2026-04-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-04-15
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-01-17
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-06-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-06-17

Official Correspondent

HUGUES CAZZANIGA

US Agent Details

Michael E Parrish Business: Tecomet, Inc. Email: mike.parrish@tecomet.com Phone: (574) 3712237

Related Public Records

Same Entity

Symmetry Medical Polyvac SAS
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-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008534770. Last updated year: 2026. Please use registration number 3008534770 when referencing this establishment in official correspondence.
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