Any Plus Spinal Fixation System

510(k) Number

K091717 ↗

FDA product code

NKB

Device class

Class II

Regulation

21 CFR Part 888.3070

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.

The first 2,000 of 5,821 devices are listed. Each device has its own page.

Other devices filed under FDA product code NKB (Thoracolumbosacral Pedicle Screw System).

• CapSure® PS System by Spine Wave, Inc.
• PERLA ® TL TLF-SC 04 00-S by Spineart
• Xpine Spinal Fixation System by Jeil Medical Corporation
• Erisma™-LP 18017545 by Clariance, Inc.
• KHEIRON 26SP67130 by S.M.A.I.O
• Erisma® Deformity Spinal System 18322055 by Clariance, Inc.
• CD Horizon™ ModuLeX™ Spinal System G25031500 by MEDTRONIC SOFAMOR DANEK, INC.
• KHEIRON® Spinal Fixation System by S.M.A.I.O
• ARSENAL SPINAL FIXATION SYSTEM by ALPHATEC SPINE, INC.
• ARx MIS Spinal Screw System by Life Spine, Inc.

• Gsst-0702-2008-Ce(4)

  Class IIb

  CE/MDD

• Gsst-0702-2008-Ce(4)

  Class IIb

  CE/MDD

• Gsst-0702-2008-Ce(4)

  Class IIb

  CE/MDD

• Gsst-0702-2008-Ce(4)

  Class IIb

  CE/MDD

See all devices from GS Medical Co., Ltd. →