SAFE ORTHOPAEDICS SAS

FDA Device Registration & Listing · Fleurieux-Sur-L'Arbresle Rhone, FR · Registration 3009509485

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
3009509485
FEI Number
3009509485
Entity Name
SAFE ORTHOPAEDICS SAS
City/State/Country
Fleurieux-Sur-L'Arbresle Rhone, FR
Establishment Address
Zone Dactivite De Montepy, 80 Rue De Montepy, Fleurieux-Sur-L'Arbresle Rhone 69210, FR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Safe Orthopaedics (Owner Number: 10039164)
Owner / Operator Contact Address
80 Rue de Montepy, 69210, FR-69 69210, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K112453
PMA Number
N/A

All Registered Proprietary Names

ROD INTRODUCER KIT Sterispine Pedicle Screw System ROD BENDER FOR 5.5MM ROD SteriSpine VA SYNTH™ Plus MEDINAUT Plus KIT OF CURVED LUMBAR CAGE RACKING COMPRESSION PLIER KIT STERISPINE LC Lumbar Interbody Device SteriSpine Pedicle screw system

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-08-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-08-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-08-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-08-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-05-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-05-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-05-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-05-22
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2013-01-07
HRX Arthroscope Orthopedic Class 2 888.1100 2026-02-24
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2026-02-24
HXG Tamp Orthopedic Class 1 888.4540 2026-02-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-03-20
HWN Instrument, Compression Orthopedic Class 1 888.4540 2014-04-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-10-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2011-12-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2011-12-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2011-12-14

Official Correspondent

Nicolas Papillon

US Agent Details

Kyle ATWOOD Business: XCIX DESIGN Email: kyle@xcixdesign.com Phone: (435) 5126808

Related Public Records

Same Entity

Safe Orthopaedics
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
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
K032604 Co-Ligne AG GII SPINAL FIXATION SYSTEM 2004-01-20
K964304 Osteonics Corp. OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY 1997-01-17
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011 Zimmer Inc. 2
SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009509485. Last updated year: 2026. Please use registration number 3009509485 when referencing this establishment in official correspondence.
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