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Wafer System

by Spine Wave, Inc.

510(k) K033303

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 · Traditional NumberK033303 Date24 Jun 2004ClearedStatusActive

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  • Withdrawn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
HRS
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Wafer System is an orthopedic device. It is classified under the product code HRS.

The Wafer System is supplied by Spine Wave, Inc. and has received FDA 510K authorization. It is described as substantially equivalent, with a clearance type of traditional.

Other devices from Spine Wave, Inc.

See all devices from Spine Wave, Inc. →

Questions

AI-generated answers, 27 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 Wafer System used for?

    The Wafer System is an orthopedic device, indicating its use in supporting or replacing spinal structures.

  • How is the Wafer System supplied?

    The Wafer System is supplied by Spine Wave, Inc., the manufacturer.

  • What regulatory authorization has the Wafer System received?

    The Wafer System has received FDA 510K authorization, indicating it is substantially equivalent to a predicate device.