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FDA 510(k)

AEQUALIS HUMERAL PLATE

K-Number: K063551 · 2006-12-22

ApplicantTornier
Decision Date2006-12-22
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AEQUALIS 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 2006-12-22 under 510(k) number K063551. 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 AEQUALIS HUMERAL PLATE?

AEQUALIS HUMERAL PLATE is a medical device that received FDA 510(k) clearance on 2006-12-22. The listed applicant is Tornier. The 510(k) number is K063551.

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

AEQUALIS HUMERAL PLATE received FDA 510(k) clearance on 2006-12-22, under 510(k) number K063551.

Who is the listed applicant for AEQUALIS 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 AEQUALIS HUMERAL PLATE?

The FDA product code for AEQUALIS 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.

K112144AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESISK111970KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENTK111902AEQUALIS SHOULDER SYSTEMK094013HLS KNEETEC SYSTEMK100142AEQUALIS REVERSED SHOULDER PROSTHESISK091870TORNIER, PITON FIXATION IMPLANT SYSTEM

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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 GlobalK253202Hoffmann LRF SystemStryker GmbHK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.

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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