VIETMEDICAL DISTRIBUTION JOINT STOCK COMPANY

FDA Device Registration & Listing · Hanoi Ha Noi, VN · Registration 3016727307

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016727307
FEI Number
3016727307
Entity Name
VIETMEDICAL DISTRIBUTION JOINT STOCK COMPANY
City/State/Country
Hanoi Ha Noi, VN
Establishment Address
89 Luong Dinh Cua, Phuong Mai Ward, Dong Da District, Hanoi Ha Noi 10000, VN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Vietmedical Distribution Joint Stock Company (Owner Number: 10085473)
Owner / Operator Contact Address
89 Luong Dinh Cua, Phuong Mai Ward, Dong Da District, Hanoi, VN-NOTA 10000, VN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K062747
PMA Number
N/A

All Registered Proprietary Names

CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO Bur, Surgical, General & Plastic Surgery MENISCAL CINCH GENERAL AND PLASTIC SURGERY Arthrex Fracture System Instrument, Special Lens, For Endoscope TABLE AND ATTACHMENTS, OPERATING-ROOM Orthopedic Manual Surgical Instrument Probe Accessories, Arthroscopic Handle, Scalpel ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 ORTHOPEDIC COMPONENT, TRACTION, NON-INVASIVE Medical device data system Camera, Surgical And Accessories Arthrex Compression Screws Blade, Saw, General & Plastic Surgery, Surgical Apparatus, Traction, Non-Powered Orthopedic Template IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-02-12
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-02-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-01-10
FWB Camera, Television, Surgical, Without Audio General, Plastic Surgery Class 1 878.4160 2025-07-25
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2023-05-23
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2022-06-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-12
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-02-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-12
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2022-06-22
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-06-22
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-06-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-06-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-06-22
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-06-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-12
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-12
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2022-06-22
HXJ Staple Driver Orthopedic Class 1 888.4540 2022-06-22
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2022-06-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-12
FEI Instrument, Special Lens, For Endoscope Gastroenterology, Urology Class 1 876.1500 2022-11-15
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-02-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-12
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2022-06-22
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-08-04
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-08-04
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-08-04
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-08-04
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-06-22
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-06-22
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2022-06-22
HXB Probe Orthopedic Class 1 888.4540 2022-07-21
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2022-06-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-06-22
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-06-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-12
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-12
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-02-12
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2022-11-15
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2025-07-25
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-02-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-12
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-06-22
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2022-06-22
HTW Bit, Drill Orthopedic Class 1 888.4540 2022-06-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-12
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-12
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 2025-07-25
OUG Medical Device Data System General Hospital Class 1 880.6310 2025-07-25
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-02-12
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-02-12
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2024-02-12
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-06-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-06-22
HRX Arthroscope Orthopedic Class 2 888.1100 2022-06-22
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2022-11-15
HRX Arthroscope Orthopedic Class 2 888.1100 2022-07-21
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-07-21
HRX Arthroscope Orthopedic Class 2 888.1100 2022-06-22
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-02-12
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-01-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-02-12
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2022-06-22
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2022-11-15
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-02-12
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-02-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-08-04
HWT Template Orthopedic Class 1 888.4800 2022-11-15
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-02-12
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-12
OSV Insufflator, Endoscopic Vessel Harvesting Obstetrics/Gynecology Class 2 884.1730 2023-05-23
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2023-05-23
FCX Insufflator, Automatic Carbon-Dioxide For Endoscope Gastroenterology, Urology Class 2 876.1500 2023-05-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-06-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-06-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-06-22
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2022-06-22
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-06-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-01-10
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2023-05-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-05-23
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2025-07-25
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-12
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-12
HRX Arthroscope Orthopedic Class 2 888.1100 2022-06-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-12
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-02-12
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2024-02-12

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

Vietmedical Distribution Joint Stock Company
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
K895079 Buckman Co., Inc. ACE BEADED K-WIRES ACE OLIVE WIRES 1989-09-13
K922193 Osteo AG OSTEO KIRSCHNER WIRE 1992-07-23
K850026 Kirkstil Corp., Inc. ORTHOPEDIC IMPLANT NAILS & PINS 1985-05-20
K963367 Rms Div. RMS K-WIRE 1996-10-30
K072322 Smith & Nephew, Inc. ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS 2007-09-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-05 Biomet, Inc. 2
Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016727307. Last updated year: 2026. Please use registration number 3016727307 when referencing this establishment in official correspondence.
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