HomeUSAIN2BONES USA, LLC

IN2BONES USA, LLC

USA · Cordova
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
14listed device types
Class I 6Class II 8Class III 0
plus 30 registration records and 27 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
17 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
19active ARTG entries
Class I 3IIa 6IIb 9Class Im (measuring) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States30 registration records, 27 510(k), 0 PMA, 2 excluded
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: IN2BONES USA, LLC · IN2BONES USA · IN2BONES, USA

Company information

Country
USA
City
Cordova

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

22016
32017
42018
22019
52020
52021
22022
12023
22024
12026

FDA listed device types

showing 8 of 14
Staple, Fixation, Bone 1Prosthesis, Elbow, Hemi-, Radial, Polymer 1Pin, Fixation, Smooth 1Prosthesis, Toe, Constrained, Polymer 1Plate, Fixation, Bone 1Screw, Fixation, Bone 1Fastener, Fixation, Nondegradable, Soft Tissue 1Washer, Bolt Nut 1

Registration details (sample)

MarketIdentifierNameClass / date
USK261154CoLink® & CoLag® Non-Sterile Screws2026-05-30
USK241387CoLink NeoFuse MIS Plating System (see attached parts list)2024-08-13
USK233089NeoSpan® Compression Implant System2024-05-24

Similar companies

Abaxis
USA · markets 9
Accorto Regulatory Solutions LLC
USA · markets 0
Accumold LLC
USA · markets 1
AccuVein Inc.
USA · markets 8
Acme Monaco Corporation
USA · markets 4
ACON Laboratories, Inc.
USA · markets 9
Is this your company? Claim the page, add information or report a data error.Claim / report an error →