Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories

K-Number: K241171 · 2024-07-25

ApplicantStryker Leibinger GmbH & Co KG
Decision Date2024-07-25
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2024-07-25 under 510(k) number K241171. 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 Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories?

Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories is a medical device that received FDA 510(k) clearance on 2024-07-25. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K241171.

When did Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories receive FDA 510(k) clearance?

Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories received FDA 510(k) clearance on 2024-07-25, under 510(k) number K241171.

Who is the listed applicant for Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories?

The FDA 510(k) record lists Stryker Leibinger GmbH & Co KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories?

The FDA product code for Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories is OLO.

Related Clinical Trials

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.

NCT04235764En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope DeviceRECRUITINGNCT05565131Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine SurgeryCOMPLETEDNCT06652568Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote DetectionCOMPLETEDNCT06958731In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled TrialENROLLING_BY_INVITATIONNCT07161024AR Projections for Eye-gaze Evaluation in PhantomsCOMPLETEDNCT07173309Evaluation of Eye Gaze Sharing in the Operating RoomRECRUITING

Other records listing Stryker Leibinger GmbH & Co KG as applicant

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.

PMA P130014Sealant, duralK261054RibPlate SystemK254233MEDPOR Customized Implant KitPMA P980052Joint, temporomandibular, implantK253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air MotorK252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories

View all 21 devices →

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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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.

↑