Foundation Interbody Devices
FDA 510(k)Class II (US FDA 510(k))
by Corelink Llc
Identifiers
- 510(k) Number
- K150847 FDA 510(k)
- FDA Product Code
- ODP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3080 FDA 510(k)
- Regulation Number
- 888.3080 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Foundation Interbody Devices are spinal interbody fusion implants designed for use in orthopedic spinal surgery. These devices are intended to provide structural support and promote spinal fusion by maintaining proper disc space height and alignment in the cervical or lumbar spine.
These devices are supplied as single-use, sterile implants and are regulated under the FDA’s 510(k) clearance pathway as Class II Orthopedic Devices (Product Code ODP). They are intended for use in surgical settings and are cleared for traditional 510(k) review after meeting substantial equivalence standards. No additional regulatory markings beyond the FDA clearance (K150847) are specified.
Frequently asked questions
Are the Foundation Interbody Devices reusable or intended for single-use in surgery?
The Foundation Interbody Devices are explicitly designed for single-use only. This is standard practice for spinal implants to ensure sterility and patient safety, as reuse could compromise integrity and introduce infection risks. The manufacturer’s documentation confirms they are supplied sterile and intended for one-time surgical application.
What spinal regions are these devices approved for use in, and how do they support spinal fusion?
These devices are cleared for use in the cervical and lumbar spine to maintain disc space height and alignment during spinal fusion surgery. By providing structural support, they help stabilize the spine and promote bone growth between vertebrae, facilitating successful fusion. The design ensures proper spacing while allowing for biological integration.
How do I verify the regulatory status of these devices before purchasing or using them?
The Foundation Interbody Devices hold an FDA 510(k) clearance (K150847) under the traditional review pathway, classified as a Class II Orthopedic Device (Product Code ODP). To confirm, check the FDA’s [510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/510k/510k.asp) using the clearance number. This ensures compliance with U.S. regulatory requirements for spinal implants.
Are there different sizes or models available for the Foundation Interbody Devices, and how might I choose the right one?
While the provided data does not list specific sizes or models, spinal interbody devices like these typically come in various dimensions to accommodate different anatomical needs (e.g., cervical vs. lumbar spine). Selection is usually based on preoperative imaging (e.g., CT or MRI) to match the patient’s disc space height and spinal alignment requirements. Consulting the manufacturer’s sizing guide or a surgeon’s recommendation is critical for proper fit.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K150847 - Foundation Interbody Devices | FDA 510 (k), Foundation Interbody Devices (K150847) — FDA 510(k) | Innolitics, F3D-C2 Stand-alone Cervical System - CoreLink Surgical, CoreLink Launches Foundation 3D Printed Titanium Interbody Cages
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150847 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Corelink Llc
- FDA Applicant
- Corelink, LLC
Sources (1)
- FDA 510(k) K150847 24 fields · synced Sep 19, 2026