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FDA 510(k)

MONOSPHERICAL GLENOID PROSTH. KEEL

K-Number: K833410 · 1983-11-07

ApplicantHowmedica Corp.
Decision Date1983-11-07
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONOSPHERICAL GLENOID PROSTH. KEEL is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1983-11-07 under 510(k) number K833410. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOSPHERICAL GLENOID PROSTH. KEEL?

MONOSPHERICAL GLENOID PROSTH. KEEL is a medical device that received FDA 510(k) clearance on 1983-11-07. The listed applicant is Howmedica Corp.. The 510(k) number is K833410.

When did MONOSPHERICAL GLENOID PROSTH. KEEL receive FDA 510(k) clearance?

MONOSPHERICAL GLENOID PROSTH. KEEL received FDA 510(k) clearance on 1983-11-07, under 510(k) number K833410.

Who is the listed applicant for MONOSPHERICAL GLENOID PROSTH. KEEL?

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 GLENOID PROSTH. KEEL?

The FDA product code for MONOSPHERICAL GLENOID PROSTH. KEEL is KWS.

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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: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, 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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