ATEC Lateral Interbody System
by Alphatec Spine, Inc. 2 variants
510(k) K202587
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK202587 | Date6 Nov 2020 | 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- Withdrawn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 ATEC Lateral Interbody System is a spinal implant designed for lateral interbody fusion procedures. It provides intervertebral support and stabilization through lateral access to the spine, facilitating fusion of adjacent vertebrae while minimizing disruption to surrounding tissues. The system is intended for use in spinal surgeries where direct anterior or posterior approaches may be less optimal.
This system is supplied sterile and intended for single-use. It is approved under FDA 510(k) clearance (K202587) as substantially equivalent to existing devices in the orthopedic category. The system includes components compatible with lateral transpsoas surgical approaches, though MRI safety and reusable components are not specified. Storage and handling follow standard sterile medical device protocols as defined by the manufacturer.
Other devices from Alphatec Spine, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the ATEC Lateral Interbody System used for?
The ATEC Lateral Interbody System is designed for lateral interbody fusion procedures in spinal surgeries. It provides intervertebral support and stabilization by accessing the spine laterally, which can be advantageous when direct anterior or posterior approaches are less suitable. This approach helps facilitate fusion of adjacent vertebrae while reducing disruption to surrounding tissues.
Is the ATEC Lateral Interbody System sterile and single-use?
Yes, the ATEC Lateral Interbody System is supplied sterile and intended for single-use only. This ensures patient safety and reduces the risk of infection or cross-contamination, adhering to standard medical device protocols for sterile implants.
What types of surgical approaches is this system compatible with?
The ATEC Lateral Interbody System is specifically designed to be compatible with lateral transpsoas surgical approaches. This type of access allows for targeted spinal fusion while minimizing exposure to critical anatomical structures.
How should the ATEC Lateral Interbody System be stored?
Storage and handling of the ATEC Lateral Interbody System follow standard sterile medical device protocols as outlined by the manufacturer. This includes maintaining the sterile packaging until immediate preoperative use and adhering to guidelines for sterile surgical environments to preserve sterility and functionality.
What regulatory clearance does the ATEC Lateral Interbody System hold?
The ATEC Lateral Interbody System holds FDA 510(k) clearance under the reference number K202587. This clearance indicates that the device is deemed substantially equivalent to existing orthopedic spinal implants, meeting regulatory standards for safety and effectiveness.