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FDA 510(k)

TunneLoc Tibial Fixation Device

K-Number: K193092 · 2020-01-02

ApplicantBiomet, Inc.
Decision Date2020-01-02
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TunneLoc Tibial Fixation Device is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2020-01-02 under approval number K193092. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TunneLoc Tibial Fixation Device?

TunneLoc Tibial Fixation Device is a medical device that received FDA 510(k) clearance on 2020-01-02. It is manufactured by Biomet, Inc.. The 510(k) number is K193092.

When was TunneLoc Tibial Fixation Device approved by the FDA?

TunneLoc Tibial Fixation Device received FDA 510(k) clearance on 2020-01-02, under approval number K193092.

What company makes TunneLoc Tibial Fixation Device?

TunneLoc Tibial Fixation Device is manufactured by Biomet, Inc..

What is the FDA product code for TunneLoc Tibial Fixation Device?

The FDA product code for TunneLoc Tibial Fixation Device is MBI.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07601230 Polyp Pretreatment Device for SSL Diagnosis NOT_YET_RECRUITING NCT06142435 mTBI Identification and Monitoring Through Retinal Scanning RECRUITING NCT07456865 Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device RECRUITING NCT04389749 Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures RECRUITING

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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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