AVS A-LAT PEEK SPACERS - 48753XXX

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K101051 ↗

FDA Product Code

MAX

Models / Variants

48750XXX

48751XXX

48752XXX

48753XXX

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Tritanium® C Anterior Cervical Cage

  Class II

  FDA 510(k) K262061 Active Cleared 17 Jul 2026

• Modification to Xia 4.5 Spinal System

  Class II

  FDA 510(k) K060748 Active Cleared 13 Apr 2006

• XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi

  Class II

  FDA 510(k) K222684 Active Cleared 8 Jun 2023

• Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal

  Class II

  FDA 510(k) K133188 Active Cleared 17 Dec 2013

• Stryker Spine Vlift Vertebral Body Replacement System

  Class II

  FDA 510(k) K060506 Active Cleared 25 May 2006

• Xia 3 Spinal System

  Class II

  FDA 510(k) K113666 Active Cleared 28 Aug 2012

See all devices from Stryker Spine →

• What is the intended use of the AVS A-LAT PEEK Spacers?

  The AVS A-LAT PEEK Spacers are intervertebral body fusion devices designed to provide structural support in the lumbar spine from L2 to S1 for patients with degenerative disc disease at one or two contiguous levels, promoting spinal fusion when used with autogenous bone graft.

• How are the AVS A-LAT PEEK Spacers supplied and what models are available?

  The spacers are supplied in four distinct model sizes: 48750XXX, 48751XXX, 48752XXX, and 48753XXX, each corresponding to a specific footprint and height to accommodate varying patient anatomies and surgical needs during intervertebral fusion procedures.

• Are the AVS A-LAT PEEK Spacers sterile and intended for single use?

  While the device data does not explicitly state sterility or single-use status, as intervertebral fusion implants, they are typically provided sterile and designed for single-use implantation; however, users should consult the product labeling for definitive instructions on handling, sterilization, and reuse limitations.

• What regulatory pathway was used for the AVS A-LAT PEEK Spacers?

  The AVS A-LAT PEEK Spacers received FDA clearance through a traditional 510(k) submission (K101051), demonstrating substantial equivalence to a predicate device, with clearance granted on August 12, 2010, under product code MAX.