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FDA 510(k)

PCA (R) TIBIAL BONE WEDGES

K-Number: K904170 · 1990-10-17

ApplicantHowmedica Corp.
Decision Date1990-10-17
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PCA (R) TIBIAL BONE WEDGES is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1990-10-17 under 510(k) number K904170. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PCA (R) TIBIAL BONE WEDGES?

PCA (R) TIBIAL BONE WEDGES is a medical device that received FDA 510(k) clearance on 1990-10-17. The listed applicant is Howmedica Corp.. The 510(k) number is K904170.

When did PCA (R) TIBIAL BONE WEDGES receive FDA 510(k) clearance?

PCA (R) TIBIAL BONE WEDGES received FDA 510(k) clearance on 1990-10-17, under 510(k) number K904170.

Who is the listed applicant for PCA (R) TIBIAL BONE WEDGES?

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 PCA (R) TIBIAL BONE WEDGES?

The FDA product code for PCA (R) TIBIAL BONE WEDGES 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 STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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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.

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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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