Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009421413

FEI Number

3009421413

Entity Name

GMED Healthcare BV (a Johnson & Johnson Company)

City/State/Country

Leeds, GB

Establishment Address

Capitol Boulevard, Capital Park West, Leeds LS27 0TS, GB

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

DePuy Synthes, Inc. (Owner Number: 1818910)

Owner / Operator Contact Address

700 Orthopaedic Drive, Warsaw, IN 46582, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112907

PMA Number

N/A

All Registered Proprietary Names

Confidence High Viscosity Spinal Cement

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2015-07-23

Official Correspondent

No official correspondent registered.

US Agent Details

Erin Combs Business: DEPUY SYNTHES, INC. Email: ecombs@its.jnj.com Phone: (574) 4048348

Related Public Records

Same Entity

DePuy Synthes, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004715683	Memphis Logistic Center	Memphis, TN, US
3015516266	Depuy Ireland UC	Co. Cork Munster, IE
1219655	DEPUY ORTHOPAEDICS, INC.	RAYNHAM, MA, US
3004464325	DEPUY ORTHOPAEDICS	BRIDGEWATER, MA, US
1818910	DEPUY ORTHOPAEDICS, INC.	WARSAW, IN, US

Similar Registrations

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3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
2648623	STERIS ISOMEDIX PUERTO RICO, INC.	Alts De Cerro Gordo 3&4, PR, US
3015309643	Merit Medical UK Limited	Earley Reading, GB
3008572623	ELMDOWN SRL UNIPERSONALE	milano Lombardy, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009421413. Last updated year: 2026. Please use registration number 3009421413 when referencing this establishment in official correspondence.