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FDA 510(k)

The Solstice OCT System

K-Number: K170804 · 2017-05-18

ApplicantLife Spine, Inc.
Decision Date2017-05-18
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Solstice OCT System 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 2017-05-18 under 510(k) number K170804. 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 The Solstice OCT System?

The Solstice OCT System is a medical device that received FDA 510(k) clearance on 2017-05-18. The listed applicant is Life Spine, Inc.. The 510(k) number is K170804.

When did The Solstice OCT System receive FDA 510(k) clearance?

The Solstice OCT System received FDA 510(k) clearance on 2017-05-18, under 510(k) number K170804.

Who is the listed applicant for The Solstice OCT System?

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 The Solstice OCT System?

The FDA product code for The Solstice OCT System is NKG.

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Related Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.

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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