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FDA 510(k)

SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF

K-Number: K153783 · 2016-05-04

ApplicantSpinevision S.A.
Decision Date2016-05-04
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF is a medical device manufactured by Spinevision S.A.. It received FDA 510(k) clearance on 2016-05-04 under approval number K153783. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF?

SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF is a medical device that received FDA 510(k) clearance on 2016-05-04. It is manufactured by Spinevision S.A.. The 510(k) number is K153783.

When was SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF approved by the FDA?

SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF received FDA 510(k) clearance on 2016-05-04, under approval number K153783.

What company makes SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF?

SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF is manufactured by Spinevision S.A..

What is the FDA product code for SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF?

The FDA product code for SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF is MAX.

Other Devices by Spinevision S.A.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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