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FDA 510(k)

Solstice CCI

K-Number: K200896 · 2020-04-28

ApplicantLife Spine, Inc.
Decision Date2020-04-28
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Solstice CCI is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2020-04-28 under 510(k) number K200896. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solstice CCI?

Solstice CCI is a medical device that received FDA 510(k) clearance on 2020-04-28. The listed applicant is Life Spine, Inc.. The 510(k) number is K200896.

When did Solstice CCI receive FDA 510(k) clearance?

Solstice CCI received FDA 510(k) clearance on 2020-04-28, under 510(k) number K200896.

Who is the listed applicant for Solstice CCI?

The FDA 510(k) record lists Life Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solstice CCI?

The FDA product code for Solstice CCI is NKG.

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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.

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