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FDA 510(k)

SPIRA Open Matrix ALIF and LLIF

K-Number: K190483 · 2019-09-23

Decision Date2019-09-23
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPIRA Open Matrix ALIF and LLIF is a medical device manufactured by Camber Spine Technologies. It received FDA 510(k) clearance on 2019-09-23 under approval number K190483. 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 SPIRA Open Matrix ALIF and LLIF?

SPIRA Open Matrix ALIF and LLIF is a medical device that received FDA 510(k) clearance on 2019-09-23. It is manufactured by Camber Spine Technologies. The 510(k) number is K190483.

When was SPIRA Open Matrix ALIF and LLIF approved by the FDA?

SPIRA Open Matrix ALIF and LLIF received FDA 510(k) clearance on 2019-09-23, under approval number K190483.

What company makes SPIRA Open Matrix ALIF and LLIF?

SPIRA Open Matrix ALIF and LLIF is manufactured by Camber Spine Technologies.

What is the FDA product code for SPIRA Open Matrix ALIF and LLIF?

The FDA product code for SPIRA Open Matrix ALIF and LLIF is MAX.

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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.