FDA Registration
Active
🇨🇦 Canada
TRIBE MEDICAL GROUP
Reg #: 3010400367
·
FEI: 3010400367
·
Expires 2026
Products
75
Proprietary Names
79
Establishment Types
1
Classifications
75
Registration Details
- Registration Name
- TRIBE MEDICAL GROUP
- Registration Number
- 3010400367
- FEI Number
- 3010400367
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 595 Industrial Road
- City
- London Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K022856
Owner / Operator
- Firm Name
- Tribe Medical Group
- Operator Number
- 10082587
- Address
- 595 Industrial Road
- City
- London
- State
- Ontario
- Postal Code
- N5V 1V2
- Country
- CA
US Agent
- Business Name
- Arthrex Inc
- Contact Name
- Barry Dietz
- Address
- 1370 Creekside Blvd
- City
- Naples
- State
- FL
- ZIP
- 34108
- Country
- US
- [email protected]
- Phone
- 800 9337001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2021-08-31 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-08-31 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2021-08-31 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2021-09-01 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2021-08-31 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2021-08-31 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2024-02-09 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2021-08-29 |
| Insufflator, Endoscopic Vessel Harvesting | OSV | Class 2 | Obstetrics/Gynecology | No | 2021-08-29 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2021-08-31 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2021-08-31 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2021-08-31 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2022-07-21 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2024-04-02 |
| Bone Wedge | PLF | Class 2 | Orthopedic | No | 2021-09-01 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2023-08-04 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2021-08-29 |
| Balance, Analytical | JQO | Class 1 | Clinical Chemistry | No | 2023-08-04 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2021-09-01 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2021-08-31 |
| Instrument, Special Lens, For Endoscope | FEI | Class 1 | Gastroenterology, Urology | No | 2023-12-08 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2021-09-01 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2021-09-01 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2021-09-01 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2021-09-01 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-08-31 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2023-12-08 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2023-08-04 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2022-06-10 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2021-08-31 |
| Staple Driver | HXJ | Class 1 | Orthopedic | No | 2021-08-27 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2021-08-26 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2021-08-31 |
| Guide, Drill, Ligament | LXI | Class 1 | General, Plastic Surgery | No | 2023-05-31 |
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2021-09-01 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2021-08-27 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2021-08-27 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2021-09-01 |
| Total Shoulder Arthroplasty System | QHQ | Class 2 | Orthopedic | No | 2021-09-01 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2021-08-29 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2022-06-02 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2022-01-19 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2024-04-02 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2021-08-29 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2021-08-29 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2021-08-31 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2022-06-10 |
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | Class 2 | General, Plastic Surgery | No | 2021-08-26 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 2021-08-26 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-09-01 |
| Staple, Absorbable | MNU | Class 2 | Orthopedic | No | 2021-08-31 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2021-09-01 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2021-09-01 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2021-09-01 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2023-08-04 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2022-06-02 |
| Camera, Television, Surgical, Without Audio | FWB | Class 1 | General, Plastic Surgery | No | 2024-04-02 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2021-08-29 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2022-06-02 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2023-12-08 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2024-04-02 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2022-06-10 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2022-11-15 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2022-07-21 |
| Template | HWT | Class 1 | Orthopedic | No | 2022-07-21 |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2021-08-31 |
| Mesh, Surgical, Collagen, Staple Line Reinforcement | OXE | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
| Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction | OXB | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2023-05-31 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2021-12-22 |
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
single/ multiple component metallic bone fixation appliances and accessories
Balance, Analytical
single contact layer
Syringe, Irrigating
Single/multiple component metallic bone fixation appliances and accessories
Arthrex Ankle Fusion Plating System
Instrument, Special Lens, For Endoscope
Sheath
Laproscopes
HUMERAL FRACTURE PLATE
DOUBLE SYRINGE (ACP) SYSTEM
WASHER, BOLT NUT
Handle, Scalpel
Fastener, fixation, nondegradable, soft tissue
Syringe, piston
Shoulder joint metal/ polymer semi-constrained cemented prosthesis
Rongeur
Protector, Skin Pressure
orthopedic manual instrument
Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener
Guide, drill, ligament
FILLER, BONE VOID, CALCIUM COMPOUND
DISPLAY, CATHODE-RAY TUBE, MEDICAL
SHAVER SYSTEM
LIGHT, SURGICAL, FIBEROPTIC
Dressing, wound, hydrophilic
Camera, Surgical And Accessories
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Instrument, manual, surgical, general use
ORTHOPEDIC MANUAL INSTRUMENTS
Wrist Drill Guide
Finger cot
Apparatus, Traction, Non-Powered
Smooth or threaded metallic bone fixation fastner
Bio-Button
Platelet and plasma separator for bone graft handling
Tray, Surgical, Instrument
Blade, Saw, General & Plastic Surgery, Surgical
Camera, Television, Surgical, Without Audio
ARTHROSCOPY PUMP
Fastener, Fixation, nondegradable, soft tissue
Arthroscope
ENDOSCOPY
HATRIC
VARIOUS INSTRUMENTS
Bur, Surgical, General & Plastic Surgery
Orthopedic manual surgical instrument
Fracture Plates & Screws
INTERFERENCE SCREW
Arthrex Fracture Plates and Screws
Arthroscopes
System, Digital Image Communications, Radiological
Reamer
GAUGE, DEPTH
Arthrex FastThread Interference Screw
PIN, FIXATION, SMOOTH
TEMPLATE
General Instruments
Dual Wave Pump
FASTAK SUTURE ANCHOR
PROSTHESIS, TOE, HEMI-, PHALANGEAL
Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis
Arthrex Univers CA Heads
System, imaging, ultrasonic
Mesh, surgical
Laparoscope, general & plastic surgery
CAMERA, SURGICAL AND ACCESSORIES
PLIERS, SURGICAL
Bit, Drill
Establishment Types
Export Device to the United States But Perform No Other Operation on Device