FDA 510(k)

Redi-Spine

K-Number: K181584 · 2018-08-10

ApplicantInnovative Surgical Designs, Inc.

Decision Date2018-08-10

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Redi-Spine is a medical device manufactured by Innovative Surgical Designs, Inc.. It received FDA 510(k) clearance on 2018-08-10 under approval number K181584. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Redi-Spine?

Redi-Spine is a medical device that received FDA 510(k) clearance on 2018-08-10. It is manufactured by Innovative Surgical Designs, Inc.. The 510(k) number is K181584.

When was Redi-Spine approved by the FDA?

Redi-Spine received FDA 510(k) clearance on 2018-08-10, under approval number K181584.

What company makes Redi-Spine?

Redi-Spine is manufactured by Innovative Surgical Designs, Inc..

What is the FDA product code for Redi-Spine?

The FDA product code for Redi-Spine is NKB.

Other Devices by Innovative Surgical Designs, Inc.

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Official Source

View on FDA Database →

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