I-MEDICAL ASIA COMPANY LIMITED

FDA Device Registration & Listing · Kowloon Bay, HK · Registration 3015806723

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
3015806723
FEI Number
3015806723
Entity Name
I-MEDICAL ASIA COMPANY LIMITED
City/State/Country
Kowloon Bay, HK
Establishment Address
Unit 18, 4/F, Block Bm Proficient Industrial Centre, 6 Wan Kwun Road, Kowloon Bay HKG, HK
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
I-Medical Asia Company Limited (Owner Number: 10085603)
Owner / Operator Contact Address
Unit 18, 4/F, Block Bm Proficient Industrial Centre, 6 Wan Kwun Road, Kowloon Bay, HK-NOTA HKG, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K151342
PMA Number
N/A

All Registered Proprietary Names

PCL TIGHTROPE LOW PROFILE PLATE AND SCREW SYSTEM Arthrex Plates, Screws, and Staples Accessories, Arthroscopic Arthrex Knee Systems Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Arthrex Fracture Plates Arthrex Short Suture Anchors Arthrex Compression Screws laparoscope, general & plastic surgery Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment ARTHREX HUMERAL FRACTURE PLATES AND SCREWS Protector, Skin Pressure Arthrex Fracture System Reamer Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads Instrument, Manual, Surgical, General Use FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE Orthopedic Manual Surgical Instrument Component, Traction, Non-Invasive Arthrex Tenodesis Button Arthrex 2.5 mm Tenodesis Screw LOW PROFILE SCREWS BIT, DRILL Camera, Surgical And Accessories

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-02-08
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2022-07-08
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-07-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-07-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-07-08
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-07-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-07-08
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-07-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-07-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-04-02
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2023-05-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-12-13
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-09
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-08
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2022-07-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2024-02-08
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2024-02-08
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2024-02-08
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-07-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-07-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-07-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-07-08
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-07-08
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2022-07-08
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2022-07-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-07-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-07-08
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2022-07-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-11-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2024-02-08
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-02-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-08
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-02-08
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-04-02
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2022-07-08
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-02-09
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2024-02-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-09
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-02-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-04-02
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-04-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-09
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-07-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-07-08
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-02-08
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2022-07-08
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-07-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-08
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-02-08
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2024-02-08
QHQ Total Shoulder Arthroplasty System Orthopedic Class 2 888.3660 2024-02-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-12-13
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-02-09
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2024-02-09
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-02-08
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2024-02-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-07-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-07-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-04-02
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-04-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-04-02
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-07-08
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2022-07-08
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-07-08
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2022-07-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-08-03
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-08-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-23
HTO Reamer Orthopedic Class 1 888.4540 2022-07-08
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-07-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-08-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-08
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-07-08
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2024-02-08
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-02-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-02-08
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-02-08
HRX Arthroscope Orthopedic Class 2 888.1100 2022-07-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-07-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-09
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2022-07-08
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-08
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2022-07-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-04-02
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2024-02-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-07-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-07-08
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-02-08
QHE Shoulder Arthroplasty Implantation System Orthopedic Class 2 888.3660 2024-02-08
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-02-08
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-07-08
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2022-07-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-07-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-07-08
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2022-07-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-07-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-07-08
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 2022-07-08
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2024-02-08
QHQ Total Shoulder Arthroplasty System Orthopedic Class 2 888.3660 2024-02-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-08
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-08
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-02-08
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-02-08
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-02-08
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2024-02-08
QHQ Total Shoulder Arthroplasty System Orthopedic Class 2 888.3660 2024-02-08
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-02-08
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-02-08
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-02-08
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-02-08
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-02-08
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-02-08
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-02-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-02-08
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-02-08
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-02-08
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2022-07-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-07-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-07-08
HTW Bit, Drill Orthopedic Class 1 888.4540 2022-07-08
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2024-02-08
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-07-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-07-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-07-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-08-27
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2022-11-14
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-07-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-07-08

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

I-Medical Asia Company Limited
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
K040336 Synthes (Usa) SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM 2004-04-12
K083648 Efratgo, Ltd. HI Tech Bio-Surgical GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL 2009-05-14
K192312 Zimmer GmbH Zimmer Natural Nail System Cephalomedullary Nails 2019-10-11
K002057 Biomet Orthopedics, Inc. BROOKER TIBIA NAILS 2000-10-04
K895079 Buckman Co., Inc. ACE BEADED K-WIRES ACE OLIVE WIRES 1989-09-13

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 3015806723. Last updated year: 2026. Please use registration number 3015806723 when referencing this establishment in official correspondence.
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