Plif Cage

510(k) Number

K113478 ↗

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).

• NGM WAVE PLIF Cage by NGMedical GmbH
• icotec Lumbar Cage PLIF 0° / 25 mm x 09 mm 12-59-02509 by icotec AG
• ARDIS INTERBODY SYSTEM by ZIMMER SPINE, INC.
• TEZO TITANIUM CAGE FAMILY by ulrich GmbH & Co. KG
• SCARLET® AL-T Intervertebral body fusion device SCA-LM 20 20-S by Spineart
• IO Expandable Lumbar Interbody Fusion System by MIRUS LLC
• Genesys Spine 3DP Lumbar Interbody System by Genesys Spine
• Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology by Pioneer Surgical Technology, Inc.
• IDYS LIF CAGES by Clariance, Inc.
• Anterior Spine Truss System (STS) Interbody Fusion Device by 4WEB INC.

• PLIF Cage 100151-250911

  Class II

  FDA 510(k) K113478 Active Cleared 5 Mar 2012 GUDID on market

• Pedicle Screw 100002-7550C

  Class II

  GUDID on market

• PLIF Cage 100179-280915

  Class II

  FDA 510(k) K113478 Active Cleared 5 Mar 2012 GUDID on market

• Pedicle Screw 100196-55200150

  Class II

  GUDID on market

See all devices from Eisertech, LLC →