Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013680140

FEI Number

3013680140

Entity Name

WISHBONE MEDICAL INC.

City/State/Country

Larwill, IN, US

Establishment Address

1560 N State Road 5, Larwill, IN 46764, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Red Star Contract Manufacturing (Owner Number: 10055139)

Owner / Operator Contact Address

1560 N State Road 5, Larwill, IN 46764, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182704

PMA Number

N/A

All Registered Proprietary Names

WishBone MG WishBone Broken Screw Removal System WishBone Plate and Screw WishFIX WishBone MG WishBone Plate and Screw WishFIX WishBone Plate and Screw WishFIX AlloMate Arthroscopic OCD Instrument System AlloMate Instrument System WishBone K-Wire System WishBone Plate and Screw WishBone MG WishBone Plate and Screw WishBone Plate and Screw WishFIX Smart Correction Wishbone Medical K-Wire System WishFIX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-12-15
HWB	Extractor	Orthopedic	Class 1	888.4540	2017-07-25
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2017-09-27
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-07-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-11-27
HWT	Template	Orthopedic	Class 1	888.4800	2018-01-25
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2021-08-27
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-08-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-06-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-06-30
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-12-15
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-02-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-02-16
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2022-02-15
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2022-07-19
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2017-12-22
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Orthopedic	Class 2	888.3030	2019-08-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Red Star Contract Manufacturing

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009631939	RED STAR CONTRACT MANUFACTURING INC.	Larwill, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013680140. Last updated year: 2026. Please use registration number 3013680140 when referencing this establishment in official correspondence.