Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006721341

FEI Number

3006721341

Entity Name

LinkBio Corp.

City/State/Country

Dover, NJ, US

Establishment Address

69 King Street, Dover, NJ 07801, US

Establishment Type(s)

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

Owner / Operator

LinkBio Corp. (Owner Number: 10022893)

Owner / Operator Contact Address

69 King Street, Dover, NJ 07801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241470

PMA Number

N/A

All Registered Proprietary Names

LinkBio Instrument Trays (Mega C) LinkBio Instrument Trays (TrabecuLink Tibial Cones) LinkBio Instrument Trays (TrabecuLink Cones Universal) CORE Shoulder Instrument Tray CORE Shoulder System Workstation Stand LinkBio Instrument LinkBio Instruments (Reamer template) LinkBio Instrument (Impactor, Impactor Plate) LinkBio Instrument (drill bit) LinkBio Instruments (LSK Femoral Sizer) LinkBio Instruments (Reamer template) LinkBio Instruments (Trials) LinkBio Instruments (Tibial cone broach) LinkBio Instruments (LSK Tensioner Blocks) LinkBio Instrument LinkBio Instruments (Broaches, Broach guide rods) CORE Shoulder System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-02-04
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2025-04-29
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-06-08
HWA	Impactor	Orthopedic	Class 1	888.4540	2022-06-08
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2022-06-08
HWT	Template	Orthopedic	Class 1	888.4800	2020-10-09
HTQ	Broach	Orthopedic	Class 1	888.4540	2021-05-13
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-04-29
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-04-29
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2025-04-29

Official Correspondent

Terry Sheridan Powell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LinkBio Corp.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K141345	Tornier S.A.S.	AEQUALIS FX2	2014-11-18
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006721341. Last updated year: 2026. Please use registration number 3006721341 when referencing this establishment in official correspondence.