FDA Registration
Active
🇫🇷 France
SYMMETRY MEDICAL POLYVAC SAS
Reg #: 3008534770
·
FEI: 3008534770
·
Expires 2026
Products
48
Proprietary Names
81
Establishment Types
2
Classifications
48
Registration Details
- Registration Name
- SYMMETRY MEDICAL POLYVAC SAS
- Registration Number
- 3008534770
- FEI Number
- 3008534770
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Parc d activites du moulin, 139 Avenue Clement Ader
- City
- WAMBRECHIES Nord
- Country
- FR
Owner / Operator
- Firm Name
- Symmetry Medical Polyvac SAS
- Operator Number
- 10042509
- Address
- Parc d'activites du moulin, 139 Avenue Clement Ader
- City
- WAMBRECHIES
- State
- Nord
- Postal Code
- 59118
- Country
- FR
- Correspondent
- HUGUES CAZZANIGA
US Agent
- Business Name
- Tecomet, Inc.
- Contact Name
- Michael E Parrish
- Address
- 3724 N State Road 15
- City
- Warsaw
- State
- IN
- ZIP
- 46582
- Country
- US
- [email protected]
- Phone
- 574 3712237
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Depth | GZL | Class 2 | Neurology | No | 2022-01-07 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2013-02-28 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2017-01-17 |
| Posterior Ratcheting Rod System | QGP | Class N | Unknown | No | 2020-09-02 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2026-04-15 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2021-06-17 |
| Dental Implant Surgical Tray | OFY | Class 1 | Dental | No | 2024-09-24 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2014-02-07 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2017-01-17 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2021-12-24 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2021-12-24 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2021-12-24 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2016-10-28 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2024-09-23 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2013-02-28 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2023-12-13 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-02-27 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2021-06-14 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2014-02-07 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2013-02-27 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2014-02-07 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2022-01-13 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2024-09-24 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2017-01-24 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2024-09-24 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2021-06-17 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2021-06-17 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2024-09-24 |
| Orthopedic Tray | OJH | Class 1 | General, Plastic Surgery | No | 2024-07-03 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2016-10-28 |
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2014-02-07 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2021-12-24 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2024-09-24 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2026-04-15 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2024-09-16 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2024-09-24 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2014-02-07 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-02-27 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2014-02-05 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2015-06-15 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-04-15 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-02-21 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2016-10-28 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2017-01-17 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2017-01-17 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2017-01-17 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2017-01-17 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2026-04-15 |
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
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
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 Pedicle Screw System
TELEGRAPH
LUXOR
GALAXY FIXATION SYSTEM
Caliper
CarboClear Lumbar Cage System
Leksell Vantage Arc Tray
Inion FreedomScrewTMInstrument tray
Inion FreedomPinTM Instrument tray
X-Twist Mini Sterilization Tray
Shoulder Arthroscopy Set
Osteotec
Universal Clamp
HYBRID FIXATOR ASSEMBLY
SHEFFIELD RING FIXATOR
KHEIRON
Sterilization Tray for Multipurpose Arc
Sterilizing Tray
Sterilization Tray Frame Fixation
Frame G Sterilization Tray
Sterilization tray Small
Sterilization Tray Needle tester
BIPOLAR I
PROCALLUS FIXATOR
ADVANCED LIMB RECONSTRUCTION SYSTEM
XCALIBER BONE SCREWS
DELTA CONTAINER SMALL
MID SYSTEM Rack
S-ROM ASIAN MILLER FRAME CASE
S-ROM ASIAN EXTRACTOR CASE
S-ROM FEM INSTR 12-18 CASE
PiGalileo TKR
DELTA 1.7MM INSTRUMENT TRAY
S-ROMASIAN REAMERS CASE
PRIMARY ACETABULAR CASE
DELTA CONTAINER LARGE
CB-2 Clamp-Sterilizationcase, 290 x 175 x 33mm
GENERIC INSTRUMENTS CASE
STERILIZATION BOX, LIGHTWEIGHT
CONTOURS PROXIMAL HUMERAL PLATE PHP
CarboClear Posterior Cervical Screw System
AEQUALIS PERFORM
CONTAINER OBTURATEUR
Activa
MILITARY EXTERNAL FIXATION CASE HOFFMANN3
NA
SMART TOE
BePOD EZ WEIL
BEPOD SCREWS 3A Percutaneous
Straumann Guided Surgical Cassette
Straumann Basic Surgical Cassette
Mont Blanc MIS Spinal Systems
Mont Blanc Spinal Systems
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device