WaveForm A Interbody System

510(k) Number

K222732 ↗

FDA product code

MAX

Device class

Class II

Regulation

21 CFR Part 888.3080

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

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

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

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

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

• ALAMO P by ALLIANCE PARTNERS LLC
• CancelleX Porous Titanium Lumbar Interbody Device by XENCO MEDICAL LLC
• COROENT SYSTEM by Nu Vasive, Incorporated
• BIOMET LATERAL SPACER SYSTEM by Biomet Spine (Aka Ebi, LLC)
• AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX by Stryker Spine
• JULIET ® Ti LL JLT-MY 50 16-S by Spineart
• MOBIS II ST SPINAL IMPLANT by SIGNUS Medizintechnik GmbH
• CONCORDE 187827109 by MEDOS INTERNATIONAL SARL
• CONCORDE 196927213 by MEDOS INTERNATIONAL SARL
• TranS1 Interbody Fusion System by Trans1

• Daytona® Small Stature 76-1030

  Class II

  FDA 510(k) K200381 Active Cleared 28 Feb 2020 GUDID on market

• Daytona® Small Stature 76-1035

  Class II

  FDA 510(k) K200381 Active Cleared 28 Feb 2020 GUDID on market

• Daytona® Small Stature 76-1040

  Class II

  FDA 510(k) K200381 Active Cleared 28 Feb 2020 GUDID on market

• Daytona® Small Stature 76-1045

  Class II

  FDA 510(k) K200381 Active Cleared 28 Feb 2020 GUDID on market

See all devices from SeaSpine Orthopedics Corporation →