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Wishbone Medical, Inc.

USA · Larwill

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Israel — 2 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

12listed device types

Class I 8Class II 4Class III 0

plus 13 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States13 registration records, 9 510(k), 0 PMA, 2 excluded

Manufacturer names merged into this page: WISHBONE MEDICAL INC.

FDA 510(k) clearances by year

12017

12018 · K180736

12019 · K182704

22020 · K203467

22022 · K221366

22023 · K231461

FDA listed device types

showing 8 of 12

Screwdriver 1Template 1Bit, Drill 1Kit, Surgical Instrument, Disposable 1Extractor 1Tape, Measuring, Rulers And Calipers 1Orthopedic Manual Surgical Instrument 1Guide, Surgical, Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231461	Smart Correction System (HA Half Pins)	2023-06-16
US	K230527	WishBone Medical Plate and Screw System	2023-03-29
US	K221366	Smart Correction System Rings and Compatible HA-Coated Half Pins	2022-06-06

Wishbone Medical, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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