Q Guidance System; Mako Spine System;
K-Number: K241517 · 2024-08-27
ApplicantStryker Leibinger GmbH & Co KG
Decision Date2024-08-27
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Q Guidance System; Mako Spine System; is a medical device manufactured by Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2024-08-27 under approval number K241517. 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 Q Guidance System; Mako Spine System;?
Q Guidance System; Mako Spine System; is a medical device that received FDA 510(k) clearance on 2024-08-27. It is manufactured by Stryker Leibinger GmbH & Co KG. The 510(k) number is K241517.
When was Q Guidance System; Mako Spine System; approved by the FDA?
Q Guidance System; Mako Spine System; received FDA 510(k) clearance on 2024-08-27, under approval number K241517.
What company makes Q Guidance System; Mako Spine System;?
Q Guidance System; Mako Spine System; is manufactured by Stryker Leibinger GmbH & Co KG.
What is the FDA product code for Q Guidance System; Mako Spine System;?
The FDA product code for Q Guidance System; Mako Spine System; is OLO.
Related Clinical Trials
NCT06011187
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
COMPLETED
NCT07173309
Evaluation of Eye Gaze Sharing in the Operating Room
RECRUITING
NCT07174479
Eye Gaze Guidance Evaluation in Phantoms
COMPLETED
NCT04488224
Nano-X Image Guidance: CBCT With Gravity-induced Motion
WITHDRAWN
NCT07589023
A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis
NOT_YET_RECRUITING
NCT05762055
Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
ENROLLING_BY_INVITATION
Related PubMed Literature
PMID: 42175114
Make Open Source Compliant: Validation in Non-Interventional Clinical Studies.
Studies in health technology and informatics (2026)
PMID: 41887630
Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa.
BMJ open (2026)
PMID: 40775863
Use of the Learning Health System to Redesign and Implement a Clinical Decision Support System for Antimicrobial Stewardship.
Studies in health technology and informatics (2025)
Other Devices by Stryker Leibinger GmbH & Co KG
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.