Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017609305

FEI Number

3017609305

Entity Name

PRIMEMED INC.

City/State/Country

Sungnam-city Gyeonggi, KR

Establishment Address

107 Intium, 1244 Sungnamdaero, Sujung-gu,, Sungnam-city Gyeonggi 13311, KR

Establishment Type(s)

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

Owner / Operator

Primemed Inc. (Owner Number: 10088830)

Owner / Operator Contact Address

107 Intium, 1244 Sungnamdaero, Sujung-gu,, Sungnam-city, KR-41 13311, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191057

PMA Number

N/A

All Registered Proprietary Names

Parks Pectus System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-10-15

Official Correspondent

Sung Dae Nam

US Agent Details

Kay Kwon Email: kaykwon@aegisspine.com Phone: (303) 5644724

Related Public Records

Same Entity

Primemed Inc.

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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

Similar Registrations

Registration Number	Establishment Name	Location
3013843055	BEIJING AK MEDICAL CO, LTD	Changping District Beijing, CN
3022777867	FIXIER S.A. DE C.V.	Doctor Mora Guanajuato, MX
3017209758	NEBULA SURGICAL PRIVATE LIMITED	Rajkot Gujarat, IN
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US
3004371426	Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017609305. Last updated year: 2026. Please use registration number 3017609305 when referencing this establishment in official correspondence.