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FDA 510(k)

Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories

K-Number: K252871 · 2026-02-06

ApplicantStryker Leibinger GmbH & Co KG
Decision Date2026-02-06
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories is a medical device manufactured by Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2026-02-06 under approval number K252871. 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 Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories?

Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories is a medical device that received FDA 510(k) clearance on 2026-02-06. It is manufactured by Stryker Leibinger GmbH & Co KG. The 510(k) number is K252871.

When was Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories approved by the FDA?

Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories received FDA 510(k) clearance on 2026-02-06, under approval number K252871.

What company makes Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories?

Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories is manufactured by Stryker Leibinger GmbH & Co KG.

What is the FDA product code for Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories?

The FDA product code for Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories is OLO.

Related Clinical Trials

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 40293498 Bridging the gap: a paradigm shift in medical device regulations in India. Naunyn-Schmiedeberg's archives of pharmacology (2025)

Other Devices by Stryker Leibinger GmbH & Co KG

K162341Stryker OrthoMap Precision Knee system K182425Universal Mesh - Sterile K191916Stryker CMF MEDPOR Priority Customized Implant Kit K221855Universal CMF System K220593Spine Guidance Software, Stryker Q Guidance System K231599Stryker MP, Mandible, HMMF and MMF AXS Screws

View all 19 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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