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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 the device name listed in this FDA 510(k) record. The listed applicant is DePuy Synthes. It received FDA 510(k) clearance on 2024-06-14 under 510(k) 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. The listed applicant is DePuy Synthes. The 510(k) number is K233254.

When did TELIGEN System Navigation Ready Instruments receive FDA 510(k) clearance?

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

Who is the listed applicant for TELIGEN System Navigation Ready Instruments?

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

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

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

Other records listing DePuy Synthes 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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