Avs A-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 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

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  FDA 510(k) K060748 Active Cleared 13 Apr 2006

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• 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.