Medical Device Manufacturer · US , Potomac , MD

In2bones Sas - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 2014
18
Total
18
Cleared
0
Denied

In2bones Sas has 18 FDA 510(k) cleared orthopedic devices. Based in Potomac, US.

Latest FDA clearance: Apr 2024. Active since 2014.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by In2bones USA as regulatory consultant.

FDA 510(k) Regulatory Record - In2bones Sas
18 devices
1-18 of 18
Cleared Apr 23, 2024
QUANTUM® Patient Specific Instrumentation (PSI) System
K231699 · HSN
Orthopedic · 316d
Cleared Apr 06, 2023
QUANTUM Patient Specific Instrumentation (PSI) System
K230313 · HSN
Orthopedic · 59d
Cleared Aug 11, 2021
QUANTUM® Patient Specific Instrumentation (PSI) System
K211883 · HSN
Orthopedic · 51d
Cleared Jan 29, 2020
Quantum® Total Ankle Prosthesis
K191380 · HSN
Orthopedic · 251d
Cleared Mar 15, 2018
TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
K173811 · HSB
Orthopedic · 90d
Cleared Jan 19, 2018
DIP Arthrodesis System
K173616 · HTY
Orthopedic · 58d
Cleared Nov 28, 2017
PIT’Stop® implant
K170688 · HWC
Orthopedic · 266d
Cleared Nov 28, 2017
Ankle Fusion Plating System
K173121 · HRS
Orthopedic · 60d
Cleared May 10, 2017
I.B.S. osteosynthesis screws
K170594 · HWC
Orthopedic · 71d
Cleared Oct 06, 2016
I.B.S. 2.0 Osteosynthesis screw
K160174 · HWC
Orthopedic · 253d
Cleared Jun 10, 2016
NEOVIEW Plating System
K160995 · HRS
Orthopedic · 63d
Cleared Mar 21, 2016
OS2(R)-VP Varisation Staple
K153770 · JDR
Orthopedic · 82d
Cleared Feb 18, 2016
OS2-C Compression Staple
K153395 · JDR
Orthopedic · 86d
Cleared Feb 01, 2016
In2Bones Kirschner wire
K153204 · HTY
Orthopedic · 89d
Cleared Feb 26, 2015
OS2-V Varisation Staple
K143323 · JDR
Orthopedic · 99d
Cleared Jul 30, 2014
DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT
K132912 · HWC
Orthopedic · 316d
Cleared May 01, 2014
STABILIZATION SCREW
K131920 · HWC
Orthopedic · 309d
Cleared Apr 04, 2014
I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW
K132911 · HWC
Orthopedic · 199d
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