FDA Registration Number: 3010370880

Last Validated: December 07, 2021

Status: Valid

Valid2021 U.S. FDA Medical Device Establishment Registration

SIMON SAS

Establishment Information

Route d Arganchy
Subles Calvados, FR 14400

U.S. Agent and Official Correspondent

Registrar Corp
144 Research Drive
Hampton VA, USA 23666
Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by U.S. FDA.

Listings on file with FDA

Device Name Product Code Status Last Validated  
Appliance, Fixation, Spinal Intervertebral Body KWQ Valid December 06, 2021

Device Listing

Device Name

Appliance, Fixation, Spinal Intervertebral Body

Product Code

KWQ

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Appliance, Fixation, Spinal Intervertebral Body
Intervertebral Fusion Device With Bone Graft, Lumbar MAX Valid December 06, 2021

Device Listing

Device Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Product Code

MAX

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Intervertebral Fusion Device with Bone Graft, Lumbar
Instrument, Cutting, Orthopedic HTZ Valid December 06, 2021

Device Listing

Device Name

Instrument, Cutting, Orthopedic

Product Code

HTZ

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Final Impactor
Bone Fixation Cerclage, Sublaminar OWI Valid December 06, 2021

Device Listing

Device Name

Bone Fixation Cerclage, Sublaminar

Product Code

OWI

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Bone Fixation Cerclage, Sublaminar OWI Valid December 06, 2021

Device Listing

Device Name

Bone Fixation Cerclage, Sublaminar

Product Code

OWI

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Bone Fixation Cerclage, Sublaminar
Guide, Surgical, Instrument FZX Valid December 06, 2021

Device Listing

Device Name

Guide, Surgical, Instrument

Product Code

FZX

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Orthosis, Spinal Pedicle Fixation MNI Valid December 06, 2021

Device Listing

Device Name

Orthosis, Spinal Pedicle Fixation

Product Code

MNI

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Bone Fixation Cerclage, Sublaminar OWI Valid December 06, 2021

Device Listing

Device Name

Bone Fixation Cerclage, Sublaminar

Product Code

OWI

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Shoulder Prosthesis, Reverse Configuration PHX Valid December 06, 2021

Device Listing

Device Name

Shoulder Prosthesis, Reverse Configuration

Product Code

PHX

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH Valid December 06, 2021

Device Listing

Device Name

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code

JWH

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Punch, Surgical LRY Valid December 06, 2021

Device Listing

Device Name

Punch, Surgical

Product Code

LRY

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Clamp, Surgical, General & Plastic Surgery GDJ Valid December 06, 2021

Device Listing

Device Name

Clamp, Surgical, General & Plastic Surgery

Product Code

GDJ

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Appliance, Fixation, Spinal Interlaminal KWP Valid December 06, 2021

Device Listing

Device Name

Appliance, Fixation, Spinal Interlaminal

Product Code

KWP

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Awl HWJ Valid December 06, 2021

Device Listing

Device Name

Awl

Product Code

HWJ

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Wrench HXC Valid December 06, 2021

Device Listing

Device Name

Wrench

Product Code

HXC

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Appliance, Fixation, Spinal Interlaminal KWP Valid December 06, 2021

Device Listing

Device Name

Appliance, Fixation, Spinal Interlaminal

Product Code

KWP

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD Valid December 06, 2021

Device Listing

Device Name

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Product Code

HSD

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Probe HXB Valid December 06, 2021

Device Listing

Device Name

Probe

Product Code

HXB

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Orthosis, Spinal Pedicle Fixation MNI Valid December 06, 2021

Device Listing

Device Name

Orthosis, Spinal Pedicle Fixation

Product Code

MNI

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE Valid December 06, 2021

Device Listing

Device Name

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code

HWE

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Bone Fixation Cerclage, Sublaminar OWI Valid December 06, 2021

Device Listing

Device Name

Bone Fixation Cerclage, Sublaminar

Product Code

OWI

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Shoulder Prosthesis, Reverse Configuration PHX Valid December 06, 2021

Device Listing

Device Name

Shoulder Prosthesis, Reverse Configuration

Product Code

PHX

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Orthopedic Manual Surgical Instrument LXH Valid December 06, 2021

Device Listing

Device Name

Orthopedic Manual Surgical Instrument

Product Code

LXH

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

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