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Abacus Spacer System

by Spine Wave, Inc.

510(k) K142101

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 NumberK142101 Date23 Oct 2014ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Abacus (Tm) Spacer System
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

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

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

Overview

AI-generated summary, 1 Oct 2026

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

The Abacus Spacer System is an intervertebral body fusion device classified under orthopedic spinal instrumentation. It is designed as a biconvex implant intended for lateral placement within the disc space to facilitate spinal stabilization and fusion procedures in the lumbar spine.

This device is introduced via the lateral approach and features textured surfaces to prevent migration. Supplied in multiple sizes, it includes an internal cavity for autograft material placement. The system has received FDA 510(k) clearance under the Traditional review pathway, with a product code of MAX and advisory committee classification under Orthopedics (OR).

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