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FDA 510(k)

UNITY HUMERAL PLATE

K-Number: K060545 · 2006-04-21

ApplicantTornier
Decision Date2006-04-21
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNITY HUMERAL PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Tornier. It received FDA 510(k) clearance on 2006-04-21 under 510(k) number K060545. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITY HUMERAL PLATE?

UNITY HUMERAL PLATE is a medical device that received FDA 510(k) clearance on 2006-04-21. The listed applicant is Tornier. The 510(k) number is K060545.

When did UNITY HUMERAL PLATE receive FDA 510(k) clearance?

UNITY HUMERAL PLATE received FDA 510(k) clearance on 2006-04-21, under 510(k) number K060545.

Who is the listed applicant for UNITY HUMERAL PLATE?

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

What is the FDA product code for UNITY HUMERAL PLATE?

The FDA product code for UNITY HUMERAL PLATE is KTT.

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Other records listing Tornier 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.

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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