Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003755939

FEI Number

3003755939

Entity Name

FARMACO QUIMICA NACIONAL, S.A.

City/State/Country

La Esperilla Santo Domingo, DO

Establishment Address

Calle Jose Aybar Castellanos, No. 155, La Esperilla Santo Domingo 10107, DO

Establishment Type(s)

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

Owner / Operator

Farmaco Quimica Nacional, S.A. (Owner Number: 10083312)

Owner / Operator Contact Address

Calle Jose Aybar Castellanos, No. 155, La Esperilla, DO-32 10107, DO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K901035

PMA Number

N/A

All Registered Proprietary Names

INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Apparatus, traction, non-powered Accessories, arthroscopic Medical Device Data System CAMERA, SURGICAL AND ACCESSORIES BUR, SURGICAL, GENERAL & PLASTIC SURGERY centrifuges (micro, ultra, refrigerated) for clinical use INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Bit, Drill Reamer MINI TIGHTROPE Orthopedic manual surgical instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FEI	Instrument, Special Lens, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2021-11-10
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-06-09
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2022-06-09
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-05-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-11-10
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-11-10
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-08-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-08-27
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2021-11-10
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-10
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2021-11-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-11-10
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2021-11-10
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2021-11-10
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-11-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-11-10
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2021-11-10
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-12-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-12-20
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2023-12-20
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2023-12-20
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2023-05-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-11-10
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2021-11-10
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2023-05-22
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-05-25
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-07-21
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-07-21
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2021-11-10
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2021-11-10
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2021-11-10
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2021-11-10
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2021-11-10
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2023-05-25
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2022-11-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-11-10
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-10
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2021-11-10
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-11-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-08-03
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2023-08-03
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-06-09
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2022-06-09
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2023-05-25
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2021-11-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-07-21
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-11-10
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2022-07-21
HTO	Reamer	Orthopedic	Class 1	888.4540	2023-08-03
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-11-10
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2022-05-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-11-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-07-24
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-07-24
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-11-10
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-11-10
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-11-10
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-10
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2021-11-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-11-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-11-10
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2021-11-10

Official Correspondent

No official correspondent registered.

US Agent Details

Barry Dietz Business: Arthrex Inc Email: Regulatory_Affairs@Arthrex.com Phone: (800) 9337001

Related Public Records

Same Entity

Farmaco Quimica Nacional, S.A.

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
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K984202	Howmedica, Inc.	HOWMEDICA HUMERAL INTERCALARY SYSTEM	1999-02-05
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.
Z-0027-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

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3008720584	Ovesco Endoscopy USA	Cary, NC, US
3010041511	Teleflex LLC (NADC)	Olive Branch, MS, US
1220246	ARTHREX, INC.	Naples, FL, US
3016851379	Arthrex Distribution Hub EMEA B.V.	Venlo Limburg, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003755939. Last updated year: 2026. Please use registration number 3003755939 when referencing this establishment in official correspondence.