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FDA 510(k)

VELYS Robotic-Assisted Solution

K-Number: K240211 · 2024-06-05

ApplicantDepuy Ireland UC
Decision Date2024-06-05
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VELYS Robotic-Assisted Solution is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2024-06-05 under 510(k) number K240211. 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 VELYS Robotic-Assisted Solution?

VELYS Robotic-Assisted Solution is a medical device that received FDA 510(k) clearance on 2024-06-05. The listed applicant is Depuy Ireland UC. The 510(k) number is K240211.

When did VELYS Robotic-Assisted Solution receive FDA 510(k) clearance?

VELYS Robotic-Assisted Solution received FDA 510(k) clearance on 2024-06-05, under 510(k) number K240211.

Who is the listed applicant for VELYS Robotic-Assisted Solution?

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

What is the FDA product code for VELYS Robotic-Assisted Solution?

The FDA product code for VELYS Robotic-Assisted Solution is OLO.

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Other records listing Depuy Ireland UC as applicant

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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.

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.

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