Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010470577

FEI Number

3010470577

Entity Name

In2Bones SAS

City/State/Country

Saint-Priest Rhone, FR

Establishment Address

Immeuble Sequoia 3, 97 Allee Alexandre Borodine, Saint-Priest Rhone 69800, FR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

In2Bones SAS (Owner Number: 10046803)

Owner / Operator Contact Address

97, Allee Alexandre Borodine, Immeuble SEQUOIA 3, Saint Priest, FR-69 69800, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211883

PMA Number

N/A

All Registered Proprietary Names

AKILINK PIT'Stop I.B.S osteosynthesis screws PIT'Stop All manual instruments OS2-VP Varisation Staple OS2-V Varisation Staple TUBE FOR KWIRE Ankle Fusion Plating System GENERIC LID REUSABLE INSTRUMENTS Drill bits Percutaneous Burr QUANTUM drill Measurer, rulers, calipers SolaFix Snap-Off Screws I.B.S. Snap-Off Screws Handle NEOSYS and DUAFIT - single use instrument kit NEOMIS Starter Quantum NEOFIT PLATE BENDER RIGHT COMPRESSOR/DISTRACTOR I.B.S. Neutralization Screws I.B.S. Osteosynthesis Screws I.B.S. Compression Screws SolaFix Neutralization Screws SolaFix Osteosynthesis Screws SolaFix Compression Screws Measurer, depth guage Interphalangeal Implant (DUAFIT) Driver, Posthesis Quantum Total Ankle Prosthesis Quantum PSI

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2018-06-11
HWA	Impactor	Orthopedic	Class 1	888.4540	2017-12-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-05-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-12-11
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-12-22
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-05-31
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-06-23
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2025-11-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-02-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-02-08
HXJ	Staple Driver	Orthopedic	Class 1	888.4540	2025-11-19
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2014-12-22
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2018-09-12
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2025-11-19
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2014-12-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-05-15
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2014-12-22
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2014-12-22
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2014-12-22
HTO	Reamer	Orthopedic	Class 1	888.4540	2021-11-04
HXW	Bender	Orthopedic	Class 1	888.4540	2025-11-19
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2025-11-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-05-15
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2014-12-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-12-22
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2016-10-20
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2020-03-06
OYK	Ankle Arthroplasty Implantation System	Orthopedic	Class 2	888.3110	2021-11-04
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-11-04

Official Correspondent

Lydia Bedre-dine

US Agent Details

Kathryn Reddig Business: ConMed Corporation Email: KathyReddig@conmed.com Phone: (727) 3995562

Related Public Records

Same Entity

In2Bones 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
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010470577. Last updated year: 2026. Please use registration number 3010470577 when referencing this establishment in official correspondence.