Skip to content

Adcura Sagittae Lateral Lumbar Interbody Fusion Devices

by Adcura, Inc.

510(k) K223065

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK223065 Date26 Oct 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

Adcura Sagittae Lateral Lumbar Interbody Fusion Devices are lateral lumbar interbody fusion devices designed for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. The device features independent height and lordosis adjustment, allowing for in-situ parallel expansion up to 16.1mm and independent lordotic adjustment up to 30 degrees to restore sagittal balance.

The device is supplied as a surgical system requiring a single instrument for in-situ height and lordotic adjustment. It is indicated for use in spinal fusion procedures and has received FDA 510(k) clearance under K223065 with product code MAX. The device is intended for use in orthopedic surgical settings and is not described as sterile, single-use, reusable, MRI safe, or having specific storage requirements in the provided data.

Questions

AI-generated answers, 28 Sep 2026

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

  • What is the Adcura Sagittae device used for?

    The Adcura Sagittae Lateral Lumbar Interbody Fusion Device is designed for interbody fusion in patients with degenerative disc disease at one or two contiguous levels from L2 to S1, helping to restore spinal alignment and stability during fusion procedures.

  • How does the Adcura Sagittae device adjust during surgery?

    The device allows for independent height and lordosis adjustment in situ, enabling parallel expansion up to 16.1mm and independent lordotic adjustment up to 30 degrees to help restore sagittal balance without removing the device from the disc space.

  • Is the Adcura Sagittae device supplied sterile or ready for immediate use?

    The provided data does not specify whether the Adcura Sagittae device is supplied sterile, single-use, or reusable, so sterility and usage status cannot be confirmed from the available information.

  • What regulatory pathway was used for the Adcura Sagittae device?

    The Adcura Sagittae Lateral Lumbar Interbody Fusion Device received FDA 510(k) clearance under submission number K223065, with product code MAX, indicating it was found substantially equivalent to a legally marketed predicate device.