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FDA 510(k)

TELIGEN System Navigation Ready Instruments

K-Number: K233254 · 2024-06-14

ApplicantDePuy Synthes
Decision Date2024-06-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TELIGEN System Navigation Ready Instruments is a medical device manufactured by DePuy Synthes. It received FDA 510(k) clearance on 2024-06-14 under approval number K233254. 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 TELIGEN System Navigation Ready Instruments?

TELIGEN System Navigation Ready Instruments is a medical device that received FDA 510(k) clearance on 2024-06-14. It is manufactured by DePuy Synthes. The 510(k) number is K233254.

When was TELIGEN System Navigation Ready Instruments approved by the FDA?

TELIGEN System Navigation Ready Instruments received FDA 510(k) clearance on 2024-06-14, under approval number K233254.

What company makes TELIGEN System Navigation Ready Instruments?

TELIGEN System Navigation Ready Instruments is manufactured by DePuy Synthes.

What is the FDA product code for TELIGEN System Navigation Ready Instruments?

The FDA product code for TELIGEN System Navigation Ready Instruments is OLO.

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Related PubMed Literature

PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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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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