SpineaSSIST System
by Mazor Surgical Technologies, Ltd. 2 variants
510(k) K063607
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063607 | Date23 Aug 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HAW
- FDA applicant
- Mazor Surgical Technologies , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The SpineaSSIST System is a robotic guidance system classified under the nomenclature for surgical navigation and robotic-assisted orthopaedic devices. It is designed to assist spine surgeons in achieving precise surgical planning and execution by integrating real-time imaging and robotic arm control during spinal procedures. The system enhances accuracy and reproducibility of surgical interventions, particularly in complex spinal surgeries.
The SpineaSSIST System is supplied as a reusable medical device intended for use in operating rooms equipped for spinal surgery. It requires sterile draping and integration with existing surgical navigation software. The system is cleared under FDA 510(k) with the product code HAW, reflecting its regulatory status as substantially equivalent to a predicate device. No specific sterility or single-use designation is noted in the data, and MRI safety considerations are not addressed in the provided specifications.
Other devices from Mazor Surgical Technologies, Ltd.
Questions
AI-generated answers, 20 Sep 2026
What types of spinal surgeries is the SpineaSSIST System designed to assist with, and how does it improve precision during procedures?
The SpineaSSIST System is designed to assist spine surgeons in complex spinal surgeries by integrating real-time imaging and robotic arm control. It enhances precision and reproducibility during surgical planning and execution, particularly in procedures requiring high accuracy, such as pedicle screw placement or laminoplasty. The robotic guidance helps reduce human error and improves alignment by providing intraoperative feedback and adjustments.
Is the SpineaSSIST System intended for single-use or reusable applications, and what are the requirements for maintaining its sterility?
The SpineaSSIST System is explicitly described as a reusable medical device. Since it is not designated as single-use, it must be thoroughly cleaned, disinfected, and sterilized between procedures according to established protocols for reusable surgical equipment. Sterile draping is required during use in the operating room to maintain a sterile field.
How is the SpineaSSIST System integrated into an operating room, and what surgical navigation software compatibility should be considered?
The SpineaSSIST System is designed to be integrated with existing surgical navigation software in operating rooms equipped for spinal surgery. It requires sterile draping and must be compatible with the navigation systems already in use at the facility. The robotic arm and imaging components work together to provide real-time guidance, so compatibility with the hospital’s imaging and planning software is critical for seamless operation.
What regulatory pathway was followed for FDA clearance of the SpineaSSIST System, and what does the product code HAW indicate?
The SpineaSSIST System was cleared under the FDA 510(k) pathway, specifically through a Traditional Review process, with a decision date of August 23, 2007. The product code HAW categorizes it under surgical navigation and robotic-assisted orthopaedic devices, indicating it is substantially equivalent to a predicate device already on the market. This classification reflects its intended use in robotic-assisted spine surgery.