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)

VADER® Pedicle System Navigated Instruments

K-Number: K230861 · 2023-06-27

ApplicantIcotec AG
Decision Date2023-06-27
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VADER® Pedicle System Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Icotec AG. It received FDA 510(k) clearance on 2023-06-27 under 510(k) number K230861. 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 VADER® Pedicle System Navigated Instruments?

VADER® Pedicle System Navigated Instruments is a medical device that received FDA 510(k) clearance on 2023-06-27. The listed applicant is Icotec AG. The 510(k) number is K230861.

When did VADER® Pedicle System Navigated Instruments receive FDA 510(k) clearance?

VADER® Pedicle System Navigated Instruments received FDA 510(k) clearance on 2023-06-27, under 510(k) number K230861.

Who is the listed applicant for VADER® Pedicle System Navigated Instruments?

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

What is the FDA product code for VADER® Pedicle System Navigated Instruments?

The FDA product code for VADER® Pedicle System Navigated Instruments is OLO.

Other records listing Icotec AG 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.

K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsK242900VADER® Pedicle System and VADER®one Pedicle SystemK233215icotec Anterior Cervical Plate SystemK232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)K232790KONG®-TL VBR System and KONG® C VBR SystemK232628VADER® Pedicle System

View all 16 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.

↑