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FDA 510(k)

BONE PLATES

K-Number: K843553 · 1984-10-01

ApplicantMecron Medical Products, Inc.
Decision Date1984-10-01
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONE PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Mecron Medical Products, Inc.. It received FDA 510(k) clearance on 1984-10-01 under 510(k) number K843553. The device is classified under product code KTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE PLATES?

BONE PLATES is a medical device that received FDA 510(k) clearance on 1984-10-01. The listed applicant is Mecron Medical Products, Inc.. The 510(k) number is K843553.

When did BONE PLATES receive FDA 510(k) clearance?

BONE PLATES received FDA 510(k) clearance on 1984-10-01, under 510(k) number K843553.

Who is the listed applicant for BONE PLATES?

The FDA 510(k) record lists Mecron Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONE PLATES?

The FDA product code for BONE PLATES is KTW.

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Other records listing Mecron Medical Products, Inc. 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: KTW)

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.

K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd.K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos)K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.K160409AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc.K122541ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)Orthofix SrlK080590AOS PROXIMAL HUMERAL PLATEAdvanced Orthopaedic Solutions, 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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