Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030089866

FEI Number

3030089866

Entity Name

ORTOLOG MEDIKAL SANAYI VE TICARET A.S.

City/State/Country

Yenimahalle Ankara, TR

Establishment Address

Ivedikkoy Mah. 1521. Cad., No: 39 Ic Kapi No: 1, Yenimahalle Ankara 06378, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ortolog Medikal Sanayi ve Ticaret A.S. (Owner Number: 10089296)

Owner / Operator Contact Address

Ivedikkoy Mah. 1521. Cad. No: 39 Ic Kapi No: 1 Yenimahalle, Ankara, TR-06 06378, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ortholox OrtholoxGh

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2023-12-04

Official Correspondent

Selcuk KESKINOL

US Agent Details

Husnu CEYLAN Business: HC Biologics LLC Email: husnu@hcbiologics.com Phone: (305) 9958211

Related Public Records

Same Entity

Ortolog Medikal Sanayi ve Ticaret A.S.

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

View Entity Profile →

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
3018033084	NEXT GENERATION TOOLING INC	Akron, OH, US
3038207124	NATIVE ORTHOPAEDICS	Providence, RI, US
3027516563	STAR SPORTS MEDICINE CO., LTD.	Beijing, CN
3021574846	3D LOGICS LLC	Hillsboro, OR, US
3008490092	CLARO PRECISION ENG LTD	Knaresborough North Yorkshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030089866. Last updated year: 2026. Please use registration number 3030089866 when referencing this establishment in official correspondence.