Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038284030

FEI Number

3038284030

Entity Name

GEUMJEONG ENG

City/State/Country

Bucheon-si Gyeonggi, KR

Establishment Address

31-1, Sinheung-ro 401beon-gil, Ojeong-gu, Bucheon-si Gyeonggi 14493, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Geumjeong ENG (Owner Number: 10093322)

Owner / Operator Contact Address

31-1, Sinheung-ro 401beon-gil, Ojeong-gu, Bucheon-si, KR-41 14493, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Genesis Dual Pitch AWL/Tapper Genesis AWL/Tapper Genesis Drill Guide Genesis AWL Genesis Drill Bit Fixone Instrument Fixone Hybrid Anchor (KP,KPN type) AlternatiV+ Max Knotless Anchor (KPN type) Genesis Knotless Anchor (KPN type)

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	2025-04-29
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-04-29

Official Correspondent

Jeongyeol Kim

US Agent Details

Peter Chung Email: peterchung210@gmail.com Phone: (412) 5128802

Related Public Records

Same Entity

Geumjeong ENG

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
K203334	Acuitive Technologies, Inc.	The Citrefix Knotless Suture Anchor	2021-02-05
K243467	Osteonic Co., Ltd.	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)	2024-12-03
K213415	OSSIO , Ltd.	OSSIOfiber Suture Anchor	2022-03-28

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
3030089866	ORTOLOG MEDIKAL SANAYI VE TICARET A.S.	Yenimahalle Ankara, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038284030. Last updated year: 2026. Please use registration number 3038284030 when referencing this establishment in official correspondence.