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SpaceVision PLIF, OLIF, TLIF

by Spinevision S.A.

510(k) K153783

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK153783 Date4 May 2016ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF
510(k) Number
FDA Product Code
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SpaceVision PLIF, OLIF, and TLIF are intervertebral body fusion cages designed for lumbar spinal stabilization. These devices are intended to promote spinal fusion, restrict motion, and alleviate pain in patients with degenerative disc disease (DDD) at one or two continuous levels from L2 to S1. They are categorized under the FDA’s product code MAX and fall under the Orthopedic advisory committee classification. The devices are engineered to address discogenic back pain confirmed by clinical history and radiographic studies.

These fusion cages are supplied by Spinevision S.A. and are classified as substantially equivalent under FDA 510(k) clearance (K153783), granted on May 4, 2016. They are intended for surgical use in spinal procedures, including posterior lumbar interbody fusion (PLIF), oblique lumbar interbody fusion (OLIF), and transforaminal lumbar interbody fusion (TLIF). The devices are not described as single-use or reusable, nor is MRI safety or sterility explicitly stated in the available data. Storage and handling instructions are not provided in the specifications.

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