Is this your brand? Sign in to claim ownership.
Sign in to claim this brandMAZOR ROBOTICS LTD
Israel·IL-MF-000020000
Last updated May 24, 2026
What MAZOR ROBOTICS LTD makes
The company manufactures reusable and single-use surgical instruments and systems for stereotactic and orthopaedic procedures, including robotic frame connection kits, cranial drill bits, and specialized clamps like the muscle biopsy clamp. Their portfolio also includes general and orthopaedic surgical procedure kits, patient drapes, and reusable instrument trays designed for precision-guided surgeries. Multi-purpose stereotactic systems and spinal instrumentation, such as guiding adaptors and Schanz screws, are also part of their offerings.
All listed devices fall under Class II regulatory classification and are registered in the FDA’s Unique Device Identifier (UDI) database. The company is based in Israel and adheres to relevant international standards for surgical and orthopaedic instrumentation.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Mazor Robotics Ltd manufacture?
Mazor Robotics Ltd specializes in surgical instruments and systems primarily for stereotactic and orthopaedic procedures. Their product range includes reusable items like stereotactic surgery probes, instrument trays, and robotic frame connection kits, as well as single-use items such as orthopaedic and general surgical procedure kits, patient drapes, and specialized tools like muscle biopsy clamps. They also produce multi-purpose stereotactic surgery systems and spinal instrumentation, including guiding adaptors and screws.
Where is Mazor Robotics Ltd based?
Mazor Robotics Ltd is based in Israel. The company’s headquarters and manufacturing operations are located within the country, though specific regional offices or production sites may vary. This location aligns with the company’s focus on developing advanced surgical technologies for global markets.
Which regulatory registries list Mazor Robotics Ltd’s devices?
Mazor Robotics Ltd’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices in the United States. The inclusion in this database reflects the company’s adherence to FDA requirements for device identification and reporting.
How are Mazor Robotics Ltd’s devices classified under medical device regulations?
All of Mazor Robotics Ltd’s listed devices fall under Class II regulatory classification. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as surgical instruments, orthopaedic implants, and precision-guided systems. Class II devices undergo rigorous evaluation to balance risk mitigation with accessibility for clinical use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Israel
- Address
- 1, HaEshel Street (Building C), Caesarea Business Park, Caesarea , Israel
- Website
- medtronic.com
- —
- —
- [email protected]
- Phone
- +97246187100
- PRRC Contact
- Marina Hefetz Lerner
- EUDAMED SRN
- IL-MF-000020000
- FDA FEI Number
- —
- DUNS Number
- 532681590
Catalogue (533)
Page 4 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| StarDriver Kit | KIT0893-05 | FDA UDI | Class II | Active |
| Head Pin 2.5x60 | MAS2267-03S | FDA UDI | Class II | Active |
| Bridge Adaptor | MAS2382-01 | FDA UDI | Class II | Unknown |
| 2.2x90mm Sleeve | MAS1782-02 | FDA UDI | Class II | Active |
| Arm 4 | MAS1384-03 | FDA UDI | Class II | Active |
| Drill Guide & Cannula - Short | KIT0139-01 | FDA UDI | Class II | Active |
| Scalpel Handle | MAS2240-06S | FDA UDI | Class II | Active |
| Mazor X Scan & Plan Disposable Kit | KIT0571-05 | FDA UDI | Class II | Active |
| Mazor X Navigation Camera | TPL0063-03 | FDA UDI | Class II | Active |
| Minimally Invasive Disposable Kit | KIT0110-03 | FDA UDI | Class II | Active |
| Head Pin 2.5x100mm, 10 pack | KIT0758-01 | FDA UDI | Class II | Unknown |
| 5.5/6.0 Arm Guide Kit | MAS2658-04 | FDA UDI | Class II | Unknown |
| Brain pre-operative supplement kit | KIT0699-01 | FDA UDI | Class II | Active |
| SIES-Short Drill 4x80, 5 pack | KIT0711-01 | FDA UDI | Class II | Active |
| Replacement Kit, Surgical System Sterile Sleeve, 10 Pack | KIT0704-01 | FDA UDI | Class II | Unknown |
| Long Drill 3.0x30, 10 pack | KIT0733-05 | FDA UDI | Class II | Active |
| Bed Mount Disposable Kit | KIT0105-03 | FDA UDI | Class II | Active |
| Mazor X Navigation Camera | TPL0063-70 | FDA UDI | Class II | Active |
| Bone Mount Bridge | MAS2188-06S | FDA UDI | Class II | Active |
| Long drill guide and Long Cannula | KIT0736-04 | FDA UDI | Class II | Active |
| SIES-Long Tapered Drill 3x80, 5 pack | KIT0715-01 | FDA UDI | Class II | Active |
| Mini Clamp | MAS2292-05S | FDA UDI | Class II | Active |
| Short Drill Guide | MAS2245-05S | FDA UDI | Class II | Active |
| Renaissance Surgical Instrument Set | KIT0614-01 | FDA UDI | Class II | Active |
| Wedge | MAS1389-03 | FDA UDI | Class II | Active |
| Scan & Plan Clamp Disposable Kit | KIT0590-05 | FDA UDI | Class II | Active |
| Brain Surgical Accessories Intra-operative Kit | KIT0295-09 | FDA UDI | Class II | Active |
| SA Reduction Tube | MAS0542-03 | FDA UDI | Class II | Active |
| SIES-Short Tapered Drill, 5 pack | KIT0710-01 | FDA UDI | Class II | Active |
| Mazor X Navigation Camera | TPL0063-02 | FDA UDI | Class II | Unknown |
| Lower Plate | MAS0522-04S | FDA UDI | Class II | Active |
| Bridge Lock | MAS2383-02 | FDA UDI | Class II | Active |
| Bone Mount Bridge | MAS2188-05S | FDA UDI | Class II | Active |
| Scan & Plan Bed Mount Disposables Kit | KIT0592-05 | FDA UDI | Class II | Active |
| 2.2x60mm Sleeve | MAS1779-02 | FDA UDI | Class II | Active |
| Brain Surgical Accessories Kit | KIT0292-07 | FDA UDI | Class II | Active |
| Target Extender Screw | MAS2345-03 | FDA UDI | Class II | Unknown |
| Rear Panel Adaptor | MAS1891-06S | FDA UDI | Class II | Active |
| Surgical Arm - Refurbished | ASM0206-03R | FDA UDI | Class II | Active |
| Clamp Disposable Kit | KIT0109-05 | FDA UDI | Class II | Active |
| Long Drill 3.0x30 | MAS2260-04 | FDA UDI | Class II | Unknown |
| Renaissance Multi Directional Bridge Set | KIT0617-01 | FDA UDI | Class II | Active |
| Sterile Clear Sleeve, 10 pack | KIT0742-01 | FDA UDI | Class II | Unknown |
| Long Drill Guide | MAS2242-06S | FDA UDI | Class II | Active |
| Clamp Link | MAS2202-04 | FDA UDI | Class II | Unknown |
| Long drill 4x80mm, 10 pack | KIT0735-05 | FDA UDI | Class II | Active |
| Short Drill Guide and Short Cannula | KIT0737-04 | FDA UDI | Class II | Active |
| SA Long Drill Guide | MAS0544-05S | FDA UDI | Class II | Active |
| Long drill guide and Long Cannula | KIT0736-02 | FDA UDI | Class II | Unknown |
| SA 3.0mm Short Drill, 10 pack | KIT0141-04 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Mazor Robotics Ltd has one FDA recall record initiated on November 26, 2014, which is marked as terminated. The recall was due to a potential issue where the carousel position pin (locker) could cause the carousel upper plate to pop out, allowing the carousel to move inadvertently.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 26, 2014 | Z-0609-2019 | — | terminated | In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move. |