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FDA 510(k)

MONOSPHERICAL SHOULDER PROSTHESIS

K-Number: K802123 · 1980-09-16

ApplicantHowmedica Corp.
Decision Date1980-09-16
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONOSPHERICAL SHOULDER PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K802123. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOSPHERICAL SHOULDER PROSTHESIS?

MONOSPHERICAL SHOULDER PROSTHESIS is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Howmedica Corp.. The 510(k) number is K802123.

When did MONOSPHERICAL SHOULDER PROSTHESIS receive FDA 510(k) clearance?

MONOSPHERICAL SHOULDER PROSTHESIS received FDA 510(k) clearance on 1980-09-16, under 510(k) number K802123.

Who is the listed applicant for MONOSPHERICAL SHOULDER PROSTHESIS?

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 MONOSPHERICAL SHOULDER PROSTHESIS?

The FDA product code for MONOSPHERICAL SHOULDER PROSTHESIS is HSD.

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Other records listing Howmedica Corp. as applicant

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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: HSD)

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K233260Univers Revers CA Head and AdapterArthrex, Inc.K221232Univers Revers Humeral Cup ImplantArthrex, Inc.K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbHK193122Biocore9 Humeral Resurfacing SystemBiocore9, LLCK173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, 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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