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Novel ALIF Spinal Spacer System

by Alphatec Spine, Inc.

510(k) K090782

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 · Special NumberK090782 Date22 Apr 2009ClearedStatusActive

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  • Withdrawn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
MAX
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

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

Cited by

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

Overview

AI-generated summary, 21 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 Novel ALIF Spinal Spacer System is a lumbar interbody fusion cage intended for use in anterior lumbar interbody fusion (ALIF) procedures. It is designed to facilitate disc removal, fusion, and spinal alignment via an anterior approach with minimal muscle disruption.

The device is intended for use with a supplemental spinal fixation system and autogenous or allogenous bone graft, specifically with the Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. It received FDA 510(k) clearance (K090782) as substantially equivalent to a predicate device and is supplied non-sterile for use in hospital settings by trained surgical personnel.

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