TRIBE MEDICAL GROUP

FDA Device Registration & Listing · London Ontario, CA · Registration 3010400367

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
3010400367
FEI Number
3010400367
Entity Name
TRIBE MEDICAL GROUP
City/State/Country
London Ontario, CA
Establishment Address
595 Industrial Road, London Ontario N5V 1V2, CA
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Tribe Medical Group (Owner Number: 10082587)
Owner / Operator Contact Address
595 Industrial Road, London, CA-ON N5V 1V2, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K151732
PMA Number
N/A

All Registered Proprietary Names

Electrosurgical, cutting & coagulation & accessories Screw, fixation, bone Fastener, fixation, biodegradable, soft tissue PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH Insufflator, laparoscopic SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE Staple, fixation, bone Plate, fixation, bone smooth or threaded metallic bone fixation fastener Fastener, fixation, biodegradable, soft tissue SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE Fastener, fixation, biodegradable, soft tissue single/ multiple component metallic bone fixation appliances and accessories Balance, Analytical smooth or threaded metallic bone fixation fastener single contact layer Screw, fixation, bone SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE Syringe, Irrigating Fastener, fixation, biodegradable, soft tissue Screw, fixation, bone SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE Single/multiple component metallic bone fixation appliances and accessories Arthrex Ankle Fusion Plating System Instrument, Special Lens, For Endoscope Fastener, fixation, biodegradable, soft tissue Fastener, fixation, biodegradable, soft tissue Fastener, fixation, biodegradable, soft tissue Sheath Laproscopes HUMERAL FRACTURE PLATE SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE DOUBLE SYRINGE (ACP) SYSTEM WASHER, BOLT NUT Handle, Scalpel Fastener, fixation, biodegradable, soft tissue Fastener, fixation, nondegradable, soft tissue Syringe, piston Shoulder joint metal/ polymer semi-constrained cemented prosthesis Rongeur Protector, Skin Pressure SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE orthopedic manual instrument Plate, fixation, bone Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener Guide, drill, ligament FILLER, BONE VOID, CALCIUM COMPOUND DISPLAY, CATHODE-RAY TUBE, MEDICAL Fastener, fixation, nondegradable, soft tissue SHAVER SYSTEM Plate, fixation, bone DISPLAY, CATHODE-RAY TUBE, MEDICAL LIGHT, SURGICAL, FIBEROPTIC PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Fastener, fixation, biodegradable, soft tissue Dressing, wound, hydrophilic Fastener, fixation, biodegradable, soft tissue PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Fastener, fixation, biodegradable, soft tissue Camera, Surgical And Accessories Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Screw, fixation, bone Staple, fixation, bone Instrument, manual, surgical, general use ORTHOPEDIC MANUAL INSTRUMENTS Wrist Drill Guide Finger cot WASHER, BOLT NUT Apparatus, Traction, Non-Powered Smooth or threaded metallic bone fixation fastner Plate, fixation, bone SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE Bio-Button Fastener, fixation, biodegradable, soft tissue SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE Fastener, fixation, nondegradable, soft tissue Staple, fixation, bone Platelet and plasma separator for bone graft handling Plate, fixation, bone Fastener, fixation, biodegradable, soft tissue Tray, Surgical, Instrument Plate, fixation, bone Blade, Saw, General & Plastic Surgery, Surgical Fastener, fixation, nondegradable, soft tissue Camera, Television, Surgical, Without Audio PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED ARTHROSCOPY PUMP Fastener, Fixation, nondegradable, soft tissue Arthroscope ENDOSCOPY HATRIC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-08-31
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-09-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-08-31
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-08-31
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-02-09
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2022-07-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-08-26
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2021-08-29
OSV Insufflator, Endoscopic Vessel Harvesting Obstetrics/Gynecology Class 2 884.1730 2021-08-29
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-09-01
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-08-31
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2021-08-31
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-08-31
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-09-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-07-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-07-21
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-04-02
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2024-04-02
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-04-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-04-02
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-09-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-01
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-05-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-05-23
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-09-01
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-09-01
PLF Bone Wedge Orthopedic Class 2 888.3030 2021-09-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2023-08-04
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-09-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-08-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 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 2021-08-31
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2021-08-29
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-05-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-05-31
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-09-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-09-01
JQO Balance, Analytical Clinical Chemistry Class 1 862.2050 2023-08-04
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
FRO Dressing, Wound, Drug Unknown Class U N/A 2021-09-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2022-01-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-12-08
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-08-31
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-08-31
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-08-29
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2021-09-01
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-08-31
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-09
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-08-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-09-01
FEI Instrument, Special Lens, For Endoscope Gastroenterology, Urology Class 1 876.1500 2023-12-08
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 2021-08-31
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-08-31
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2021-09-01
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-09-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01
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
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-09-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-01
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-09-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-09-01
HRX Arthroscope Orthopedic Class 2 888.1100 2021-09-01
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-08-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-08-27
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2021-09-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2021-09-01
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2021-09-01
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-08-31
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-02-09
FMF Syringe, Piston General Hospital Class 2 880.5860 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-04-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-04-02
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2023-05-23
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2023-12-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
FMF Syringe, Piston General Hospital Class 2 880.5860 2021-08-31
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-09-01
HTX Rongeur Orthopedic Class 1 888.4540 2023-08-04
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2022-06-10
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-08-31
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2021-08-31
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-08-31
HXJ Staple Driver Orthopedic Class 1 888.4540 2021-08-27
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2021-08-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2021-08-26
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2021-08-31
LXI Guide, Drill, Ligament General, Plastic Surgery Class 1 878.4820 2023-05-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-09-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-01
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-08-31
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-09-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
DXJ Display, Cathode-Ray Tube, Medical Cardiovascular Class 2 870.2450 2021-09-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-08-27
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2021-08-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
DXJ Display, Cathode-Ray Tube, Medical Cardiovascular Class 2 870.2450 2021-09-01
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2021-08-27
HRX Arthroscope Orthopedic Class 2 888.1100 2021-09-01
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2021-09-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-08-31
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-08-31
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-08-31
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2024-04-02
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-04-02
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-04-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-04-02
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2024-04-02
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-04-02
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2021-09-01
QHQ Total Shoulder Arthroplasty System Orthopedic Class 2 888.3660 2021-09-01
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2021-08-29
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2023-05-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-04-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-04-02
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-04-02
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2021-08-31
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-08-31
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-08-31
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2022-06-02
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2022-01-19
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2023-05-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-09-01
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2024-04-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-11-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-08-31
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2021-08-31
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2021-08-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-05-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-05-23
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2021-08-29
LZB Finger Cot General Hospital Class 1 880.6250 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-08-31
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2022-06-10
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2023-05-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-08-31
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-07-21
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-08-26
GAS Suture, Nonabsorbable, Synthetic, Polyester General, Plastic Surgery Class 2 878.5000 2021-08-26
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2021-08-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-09-01
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2023-08-04
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2023-05-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-08-31
QHQ Total Shoulder Arthroplasty System Orthopedic Class 2 888.3660 2024-04-02
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2024-04-02
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2021-08-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-08-31
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-09-01
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
MNU Staple, Absorbable Orthopedic Class 2 888.3030 2021-08-31
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-08-27
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2021-08-31
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2024-08-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-08-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-08-31
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-09-01
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-09-01
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-09-01
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2023-08-04
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-08-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-08-31
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2022-06-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-07-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-07-21
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-08-31
FWB Camera, Television, Surgical, Without Audio General, Plastic Surgery Class 1 878.4160 2024-04-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-08-31
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-08-31
HRX Arthroscope Orthopedic Class 2 888.1100 2021-09-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-01
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-09-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2023-05-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-02-09
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2024-02-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-02-09
HRX Arthroscope Orthopedic Class 2 888.1100 2021-09-01
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-08-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-01

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

Tribe Medical Group
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
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
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.

Similar Registrations

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3007353760 ENERGIST LIMITED Swansea, GB
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3012616488 BRERA MEDICAL INCORPORATED Northborough, MA, US
3012940012 Sutter Medical Technologies USA Inc. Alpharetta, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010400367. Last updated year: 2026. Please use registration number 3010400367 when referencing this establishment in official correspondence.
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