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Foundation Interbody Devices

by Corelink LLC

510(k) K150847

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150847 Date13 Aug 2015ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ODP
FDA applicant
Corelink, LLC
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

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