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FDA 510(k)

X-spine Cortical Bone Screw System

K-Number: K180153 · 2018-03-15

ApplicantX-Spine Systems, Inc.
Decision Date2018-03-15
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

X-spine Cortical Bone Screw System is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2018-03-15 under 510(k) number K180153. 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 X-spine Cortical Bone Screw System?

X-spine Cortical Bone Screw System is a medical device that received FDA 510(k) clearance on 2018-03-15. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K180153.

When did X-spine Cortical Bone Screw System receive FDA 510(k) clearance?

X-spine Cortical Bone Screw System received FDA 510(k) clearance on 2018-03-15, under 510(k) number K180153.

Who is the listed applicant for X-spine Cortical Bone Screw System?

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

What is the FDA product code for X-spine Cortical Bone Screw System?

The FDA product code for X-spine Cortical Bone Screw System is NKB.

Related Clinical Trials

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Other records listing X-Spine Systems, Inc. as applicant

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Related Devices (Code: NKB)

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.

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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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