Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015383864

FEI Number

3015383864

Entity Name

S.M.A.I.O

City/State/Country

SAINT-PRIEST Auvergne-Rhone-Alpes, FR

Establishment Address

2 Place Berthe Morisot, Parc Technologique, SAINT-PRIEST Auvergne-Rhone-Alpes 69800, FR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

S.M.A.I.O (Owner Number: 10077967)

Owner / Operator Contact Address

2 Place Berthe Morisot, Parc Technologique, SAINT-PRIEST, FR-ARA 69800, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

L120mm rod template L60mm rod template L500mm rod template Short square awl Diameter 6 rod pusher Diameter 5.5 rod pusher Left diameter 6 rod coronal bender 7mm nut driver French bender Right diameter 6 rod sagittal bender Left diameter 6 rod sagittal bender Left diameter 5.5 rod sagittal bender Right diameter 6 rod coronal bender Left diameter 5.5 rod coronal bender Right diameter 5.5 rod coronal bender Right diameter 5.5 rod sagittal bender Ti K-rod for DePuy Synthes Ti K-ROD for Orthofix K-BALL KHEIRON Axial connector impactor Parallel connector holder 1/4" T-rachet handle Connector holder Sacral plate drilling guide Left 60deg S2 cap guide Short straight extension Tulip connector holder 7mm screwdriver Pedicle screw counter torque Sacral plate extension breaker 9mm nut driver Rod gripper Sacral screw holder Nut breaker sleeve 1/4" straight handle 1/4" T-handle 1/4" straight ratchet handle Distractor Sacral screw drill Nut breaker counter torque Long straight extension Plate holder Right 90deg S2 cap guide Left 90deg S2 cap guide Sacral connector holder Nut breaker Rod holder 1/4" straight medium handle Right 60deg S2 cap guide Axial connector holder Compressor Bicortical depth gauge Straight pedicle probe Straight feeler depth gauge Straight feeler Pedicle marker Curved pedicle probe KEOPS BALANCE ANALYZER 3D KHEIRON Derotation wrench Large Hudson nut driver 7mm screwdriver Nut driver 3.5mm screwdriver Revision nut driver 4.5mm screwdriver Pedicle screwdriver Large Hudson pedicle screwdriver Post Nut Driver KHEIRON Spinal Fixation System, non-sterile implants Diameter 7.5 screw tap Diameter 6.5 screw tap Diameter 5.5 screw tap Diameter 4.5 screw tap KHEIRON KHEIRON

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWT	Template	Orthopedic	Class 1	888.4800	2020-12-16
HWJ	Awl	Orthopedic	Class 1	888.4540	2020-12-16
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2020-12-16
HXW	Bender	Orthopedic	Class 1	888.4540	2020-12-16
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-14
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-14
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-14
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	Class 1	892.1640	2023-12-20
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-10-08
HWA	Impactor	Orthopedic	Class 1	888.4540	2020-12-16
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2020-12-16
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2020-12-16
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2020-12-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-05-23
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-01-02
HXC	Wrench	Orthopedic	Class 1	888.4540	2020-12-16
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2020-12-15
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-11-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-11-19
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2020-12-16
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2023-06-02
HXB	Probe	Orthopedic	Class 1	888.4540	2023-06-02

Official Correspondent

Jean-Charles Roussouly

US Agent Details

Stephan Toupin Business: DAWA MEDICAL LLC Email: customerservices@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

S.M.A.I.O

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
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09

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 3015383864. Last updated year: 2026. Please use registration number 3015383864 when referencing this establishment in official correspondence.