Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1648571

FEI Number

3000205950

Entity Name

KB Components Dallas, Inc.

City/State/Country

ARLINGTON, TX, US

Establishment Address

4304 Larry Ln, ARLINGTON, TX 76017, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KB Components Dallas Inc. (Owner Number: 1641817)

Owner / Operator Contact Address

4304 LARRY LANE, --, Arlington, TX 76017, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

QFC-450 QFC-853, QFC-854, QFC-850 QFC-105, QFC-106 QFC-750B, QFC-950B QFC-250-RS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	1997-06-19
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2006-11-17
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2006-11-17
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	1995-11-28
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1995-12-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KB Components Dallas 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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

Similar Registrations

Registration Number	Establishment Name	Location
3009973336	Engineered Medical Systems, LLC	Bartlett, TN, US
3015384437	Care Surgical Limited	Burscough Lancashire, GB
2027754	OSTEOMED	ADDISON, TX, US
3005031160	Xtant Medical Holdings, Inc.	Belgrade, MT, US
1932668	MOLDED PRODUCTS INC.	HARLAN, IA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1648571. Last updated year: 2026. Please use registration number 1648571 when referencing this establishment in official correspondence.