FDA 510(k)

CD Horizon Spinal System and PASS LP Spinal System

K-Number: K220724 · 2022-04-08

Decision Date2022-04-08

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CD Horizon Spinal System and PASS LP Spinal System is a medical device manufactured by Medicrea International. It received FDA 510(k) clearance on 2022-04-08 under approval number K220724. 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 CD Horizon Spinal System and PASS LP Spinal System?

CD Horizon Spinal System and PASS LP Spinal System is a medical device that received FDA 510(k) clearance on 2022-04-08. It is manufactured by Medicrea International. The 510(k) number is K220724.

When was CD Horizon Spinal System and PASS LP Spinal System approved by the FDA?

CD Horizon Spinal System and PASS LP Spinal System received FDA 510(k) clearance on 2022-04-08, under approval number K220724.

What company makes CD Horizon Spinal System and PASS LP Spinal System?

CD Horizon Spinal System and PASS LP Spinal System is manufactured by Medicrea International.

What is the FDA product code for CD Horizon Spinal System and PASS LP Spinal System?

The FDA product code for CD Horizon Spinal System and PASS LP Spinal System is NKB.

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Related Devices (Code: NKB)

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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.