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FDA 510(k)

Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap

K-Number: K172034 · 2017-10-18

ApplicantStryker Corporation
Decision Date2017-10-18
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2017-10-18 under 510(k) number K172034. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap?

Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Stryker Corporation. The 510(k) number is K172034.

When did Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap receive FDA 510(k) clearance?

Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap received FDA 510(k) clearance on 2017-10-18, under 510(k) number K172034.

Who is the listed applicant for Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap?

The FDA 510(k) record lists Stryker Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap?

The FDA product code for Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap is OLO.

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Related Devices (Code: OLO)

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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