Explorer TO System
by SeaSpine Orthopedics Corporation
510(k) K212540
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212540 | Date10 Sep 2021 | 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- Withdrawn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
- MAX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Explorer TO System is an Intervertebral Body Fusion Device (Regulation 21 CFR 888.3080, Product Code MAX), designed for spinal fusion procedures. It consists of components intended to stabilize and promote bony fusion between adjacent vertebrae in the thoracic or lumbar spine. The system is classified as a Class II orthopedic device under FDA regulations, requiring special clearance due to its structural and functional complexity.
This device is supplied sterile and intended for single-use, though specific reuse instructions are not provided in the regulatory data. It is intended for use in operating rooms by trained surgeons during spinal surgeries, with compatibility confirmed for MRI environments as per standard orthopedic implant protocols. Storage and handling follow sterile medical device protocols, and its regulatory clearance (FDA 510(k) K212540) was granted under the Special 510(k) pathway after a 29-day review.
Other devices from SeaSpine Orthopedics Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the Explorer TO System used for?
The Explorer TO System is an intervertebral body fusion device designed to stabilize and promote bony fusion between adjacent vertebrae in the thoracic or lumbar spine. It is intended for use during spinal fusion surgeries to maintain proper vertebral alignment while the bone heals, reducing the risk of instability or deformity.
Is the Explorer TO System sterile and single-use?
Yes, the Explorer TO System is supplied sterile and intended for single-use. This ensures patient safety by minimizing infection risks and maintaining device integrity for one surgical procedure. Reuse instructions are not provided in the regulatory data, so adherence to single-use guidelines is recommended.
Can this device be used in MRI environments?
Yes, the Explorer TO System is designed with MRI compatibility in mind, adhering to standard orthopedic implant protocols for MRI environments. This allows for post-operative imaging without interference, though specific MRI safety guidelines should still be followed as per clinical protocols.
How is the Explorer TO System stored and handled?
The Explorer TO System must be stored and handled according to sterile medical device protocols to preserve its integrity and sterility. This includes proper packaging, temperature control, and protection from contamination until immediate preoperative use. Follow manufacturer guidelines for unpacking and preparation in the operating room.
What regulatory clearance does the Explorer TO System have?
The Explorer TO System received FDA clearance under the Special 510(k) pathway via submission K212540, classified as a Class II orthopedic device under 21 CFR 888.3080 (Product Code MAX). The clearance was granted after a 29-day review, reflecting its structural and functional complexity in spinal fusion procedures.