JOINSMART BIOMEDICAL CO., LTD.

FDA Device Registration & Listing · Tapei Taipei, TW · Registration 3015539532

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
3015539532
FEI Number
3015539532
Entity Name
JOINSMART BIOMEDICAL CO., LTD.
City/State/Country
Tapei Taipei, TW
Establishment Address
Room A, 9F, No. 351, Xingshan Rd., Tapei Taipei 11469, TW
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Joinsmart Biomedical Co., Ltd. (Owner Number: 10084852)
Owner / Operator Contact Address
Room A, 9F, No. 351, Xingshan Rd., Tapei, TW-TPE 11469, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K110123
PMA Number
N/A

All Registered Proprietary Names

Mini Tightrope Component, Traction, Non-Invasive Reamer Bit, Drill SutureTape Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment MENISCAL CINCH Table And Attachments, Operating-Room Instrument, Manual, Surgical, General Use Blade, Saw, General & Plastic Surgery, Surgical Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Orthopedic Manual Surgical Instrument Apparatus, Traction, Non-Powered Accessories, Arthroscopic PCL TIGHTROPE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-07
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-07
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-04-07
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 2022-04-07
HRX Arthroscope Orthopedic Class 2 888.1100 2022-04-07
HTO Reamer Orthopedic Class 1 888.4540 2022-04-07
HTW Bit, Drill Orthopedic Class 1 888.4540 2022-04-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-07
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-04-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-01-10
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-01-10
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-07
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-04-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-07
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2022-04-07
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2022-04-07
HRX Arthroscope Orthopedic Class 2 888.1100 2022-04-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-07
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-07
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-07
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-04-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-07
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-04-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-07
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2022-04-07
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2023-05-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-07
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-07
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2022-04-07
HRX Arthroscope Orthopedic Class 2 888.1100 2022-07-21
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2022-04-07
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-04-07
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2022-04-07
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2022-04-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-07
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-07
HRX Arthroscope Orthopedic Class 2 888.1100 2024-02-09
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-02-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-07
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-07
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2022-04-07
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-04-07
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2022-04-07
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-04-07
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2022-04-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-04-07
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-04-07
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2022-04-07
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2022-04-07
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-04-07

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

Joinsmart Biomedical Co., Ltd.
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
K193295 Parcus Medical, LLC Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor 2020-01-23
K193606 Conmed Corporation Y-Knot OneStep Anchor 2020-01-22
K984200 R. Thomas Grotz, M.D., Inc. STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE 1999-01-21
K171060 Riverpoint Medical OrthoButton AL 2017-06-02
K231867 Paragon 28, Inc. Grappler Suture Anchor System 2023-08-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.
Z-0021-2015 Biomet, Inc. 1
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
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

Similar Registrations

Registration Number Establishment Name Location
1219930 Covidien North Haven, CT, US
3016660811 SUBCHONDRAL SOLUTIONS Costa Mesa, CA, US
1054811 Sterigenics U.S. LLC MULBERRY, FL, US
3016851379 Arthrex Distribution Hub EMEA B.V. Venlo Limburg, NL
3011989923 DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Istanbul, TR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015539532. Last updated year: 2026. Please use registration number 3015539532 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.