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FDA 510(k)

DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

K-Number: K980632 · 1998-12-11

ApplicantHowmedica Corp.
Decision Date1998-12-11
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1998-12-11 under 510(k) number K980632. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION?

DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION is a medical device that received FDA 510(k) clearance on 1998-12-11. The listed applicant is Howmedica Corp.. The 510(k) number is K980632.

When did DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION receive FDA 510(k) clearance?

DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION received FDA 510(k) clearance on 1998-12-11, under 510(k) number K980632.

Who is the listed applicant for DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION?

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 DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION?

The FDA product code for DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION is JWH.

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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 STERILIZATIONK983419HOFFMANN II MIAMI POST

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Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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