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FDA 510(k)

BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD

K-Number: K915596 · 1992-03-11

ApplicantBiomet, Inc.
Decision Date1992-03-11
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1992-03-11 under 510(k) number K915596. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD?

BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD is a medical device that received FDA 510(k) clearance on 1992-03-11. The listed applicant is Biomet, Inc.. The 510(k) number is K915596.

When did BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD receive FDA 510(k) clearance?

BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD received FDA 510(k) clearance on 1992-03-11, under 510(k) number K915596.

Who is the listed applicant for BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD?

The FDA 510(k) record lists Biomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD?

The FDA product code for BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD is KWT.

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Other records listing Biomet, Inc. as applicant

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Related Devices (Code: KWT)

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.

K262173N22 Offset Humeral HeadShoulder Innovations, Inc.K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbHK241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast 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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