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FDA 510(k)

HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM

K-Number: K982068 · 1998-08-31

ApplicantHowmedica Corp.
Decision Date1998-08-31
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1998-08-31 under 510(k) number K982068. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM?

HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM is a medical device that received FDA 510(k) clearance on 1998-08-31. The listed applicant is Howmedica Corp.. The 510(k) number is K982068.

When did HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM receive FDA 510(k) clearance?

HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM received FDA 510(k) clearance on 1998-08-31, under 510(k) number K982068.

Who is the listed applicant for HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM?

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 HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM?

The FDA product code for HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM is JDW.

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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: JDW)

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.

K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLCK241357XT3 SystemBiodynamik, Inc.K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.K211508Steinmann Pins and Kirschner WiresStryker 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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