Medical Device Manufacturer · US , Memphis , TN

In2bones USA, LLC

25 submissions · 25 cleared · Since 2016
25
Total
25
Cleared
0
Denied

In2bones USA, LLC — FDA 510(k) Submissions

In2bones USA, LLC has submitted 25 FDA 510(k) premarket notifications since 2016, of which 25 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plate, Fixation, Bone, Screw, Fixation, Bone, Prosthesis, Elbow, Hemi-, Radial, Polymer, Prosthesis, Toe, Constrained, Polymer, Staple, Fixation, Bone . Use the specialty filter in the sidebar to narrow results.

25 devices
1–25 of 25
NeoSpan? Compression Implant System
K233089 · HRS Plate, Fixation, Bone · Orthopedic
May 2024 241d
IBS-B MIS Beveled Screw System
K231236 · HWC Screw, Fixation, Bone · Orthopedic
Jul 2023 90d
CoLink PCR Plating System
K213698 · HRS Plate, Fixation, Bone · Orthopedic
May 2022 185d
Hercules Syndesmosis Implant System
K220260 · HTN Washer, Bolt Nut · Orthopedic
Mar 2022 59d
Avenger Radial Head System
K212872 · KWI Prosthesis, Elbow, Hemi-,... · Orthopedic
Dec 2021 99d
CoLink NeoFuse Plating System
K213069 · HRS Plate, Fixation, Bone · Orthopedic
Dec 2021 81d
CoLink Vallux Plating System
K212487 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2021 101d
CoLink Sfx Implant System
K203698 · HTY Pin, Fixation, Smooth · Orthopedic
May 2021 137d
CoLink Mfx Implant System
K210060 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2021 60d
Hercules Suture Anchor System
K201636 · MBI Fastener, Fixation,... · Orthopedic
Aug 2020 65d
CoLink Plating System
K201149 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2020 77d
CoLink Cfx Plating System
K200762 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2020 30d
CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System
K193543 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2020 28d
Avenger Radial Head System
K192754 · KWI Prosthesis, Elbow, Hemi-,... · Orthopedic
Jan 2020 99d
CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System
K190385 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2019 170d
CoLink? Mini Plating System
K191535 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2019 49d
CoLink View Plating System
K182402 · HRS Plate, Fixation, Bone · Orthopedic
Sep 2018 23d
Fracture and Correction System
K180377 · HWC Screw, Fixation, Bone · Orthopedic
Jun 2018 128d
CoLink? Afx Plating System
K181113 · HRS Plate, Fixation, Bone · Orthopedic
Jun 2018 49d
RTS Lesser MTP Implant System
K173491 · KWH Prosthesis, Toe,... · Orthopedic
Feb 2018 102d
CoLink View Plating System
K172300 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2017 119d
In2Bones Fracture and Correction System
K170518 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2017 143d
Colink? Plating System
K163293 · HRS Plate, Fixation, Bone · Orthopedic
May 2017 164d
NeoSpan Compression Staple Impant w/instruments
K161426 · JDR Staple, Fixation, Bone · Orthopedic
Oct 2016 154d
RTS Flexible 1 MPJ Implant w/Grommets
K153609 · KWH Prosthesis, Toe,... · Orthopedic
Sep 2016 266d
Filters
All25 Orthopedic 25