Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009251316

FEI Number

3009251316

Entity Name

PT. TRANSMEDIC INDONESIA

City/State/Country

Jakarta, ID

Establishment Address

Perkantoran Menara ERA, Unit G-01, Jl. Senen No. 135-137, Jakarta 10410, ID

Establishment Type(s)

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

Owner / Operator

PT. Transmedic Indonesia (Owner Number: 10095308)

Owner / Operator Contact Address

Perkantoran Menara ERA, Unit G-01, Jl. Senen No. 135-137, Jakarta, ID-JK 10410, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Apparatus, traction, non-powered orthopedic manual surgical instrument Accessories, arthroscopic table and attachments, operating-room instrument, surgical, orthopedic, ac-powered motor and accessory/attachment

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2026-02-23
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2026-02-23
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2026-02-23
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2026-02-23
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2026-02-23

Official Correspondent

No official correspondent registered.

US Agent Details

David Rogers Email: regulatory_affairs@arthrex.com Phone: (800) 9337001

Related Public Records

Same Entity

PT. Transmedic Indonesia

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
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
2087341	GIBBONS HEALTH PRODUCTS, INC.	STUDIO CITY, CA, US
3004012851	IHN, INC	Okemos, MI, US
3023187489	MAGNATE HEALTH TECH. CO., LTD	TAIPEI CITY, TW
3014680784	Domico Med-Device, LLC	Fenton, MI, US
2936485	STRYKER ENDOSCOPY	SAN JOSE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009251316. Last updated year: 2026. Please use registration number 3009251316 when referencing this establishment in official correspondence.