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FDA 510(k)

ORTHOPEDIC FIXATION DEVICES

K-Number: K821566 · 1982-06-03

ApplicantHowmedica Corp.
Decision Date1982-06-03
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIC FIXATION DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1982-06-03 under 510(k) number K821566. 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 ORTHOPEDIC FIXATION DEVICES?

ORTHOPEDIC FIXATION DEVICES is a medical device that received FDA 510(k) clearance on 1982-06-03. The listed applicant is Howmedica Corp.. The 510(k) number is K821566.

When did ORTHOPEDIC FIXATION DEVICES receive FDA 510(k) clearance?

ORTHOPEDIC FIXATION DEVICES received FDA 510(k) clearance on 1982-06-03, under 510(k) number K821566.

Who is the listed applicant for ORTHOPEDIC FIXATION DEVICES?

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

What is the FDA product code for ORTHOPEDIC FIXATION DEVICES?

The FDA product code for ORTHOPEDIC FIXATION DEVICES is KTW.

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Other records listing Howmedica Corp. 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.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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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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