Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011944170

FEI Number

3011944170

Entity Name

ZAPALIGN INC.

City/State/Country

Anyang-si Gyeonggi, KR

Establishment Address

#1004, 10F, 181, Simin-daero, Dongan-gu,, Anyang-si Gyeonggi 14047, KR

Establishment Type(s)

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

Owner / Operator

Zapalign Inc. (Owner Number: 10091758)

Owner / Operator Contact Address

B-1001, U-space2, 670, Daewangpangyo-ro, Bundang-gu,, Seongnam-si,, KR-41 13494, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MIXEVAC CEMENT MIXERS BUR, SURGICAL, GENERAL & PLASTIC SURGERY PROVI CEMENT COLORADO MICRO DISSECTION NEEDLE SYSTEM, SKIN CLOSURE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2026-04-01
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-04-23
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2025-06-12
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2026-06-08
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2026-04-07
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2026-04-07
EMA	Cement, Dental	Dental	Class 2	872.3275	2025-05-28
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2026-04-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-06-12
MKY	System, Skin Closure	General, Plastic Surgery	Class 1	878.4320	2026-05-04

Official Correspondent

ByeongGeon Song

US Agent Details

Marty Trabish Business: Zapalign LLC Email: marty.trabish@zapalign.com Phone: (786) 4793208

Related Public Records

Same Entity

Zapalign 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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
3020117925	ATHLOS OY	Espoo Uusimaa, FI
3011326671	STERI-SHIELD INCORPORATED	Fernandina Beach, FL, US
3015168527	Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, CN
3015509619	DURR DENTAL SE	Bietigheim-Bissingen Baden-Wurttemberg, DE
3016170492	SHANGHAI ALWINGS MEDICAL INSTRUMENT CO.,LTD.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011944170. Last updated year: 2026. Please use registration number 3011944170 when referencing this establishment in official correspondence.