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FDA 510(k)

BIOMET MODULAR SHOULDER PROSTHESIS

K-Number: K872454 · 1987-08-27

ApplicantBiomet, Inc.
Decision Date1987-08-27
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BIOMET MODULAR SHOULDER PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1987-08-27 under 510(k) number K872454. 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 BIOMET MODULAR SHOULDER PROSTHESIS?

BIOMET MODULAR SHOULDER PROSTHESIS is a medical device that received FDA 510(k) clearance on 1987-08-27. The listed applicant is Biomet, Inc.. The 510(k) number is K872454.

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

BIOMET MODULAR SHOULDER PROSTHESIS received FDA 510(k) clearance on 1987-08-27, under 510(k) number K872454.

Who is the listed applicant for BIOMET MODULAR SHOULDER PROSTHESIS?

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 BIOMET MODULAR SHOULDER PROSTHESIS?

The FDA product code for BIOMET MODULAR SHOULDER PROSTHESIS is KWT.

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Other records listing Biomet, Inc. 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.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

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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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