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FDA 510(k)

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis

K-Number: K160071 · 2016-06-16

ApplicantBiomet, Inc.
Decision Date2016-06-16
Product CodeMBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

StageOne Disposable Cement Spacer Molds for Temporary Hemi-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 2016-06-16 under 510(k) number K160071. The device is classified under product code MBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis?

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is Biomet, Inc.. The 510(k) number is K160071.

When did StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis receive FDA 510(k) clearance?

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis received FDA 510(k) clearance on 2016-06-16, under 510(k) number K160071.

Who is the listed applicant for StageOne Disposable Cement Spacer Molds for Temporary Hemi-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 StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis?

The FDA product code for StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis is MBB.

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: MBB)

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.

K252443SpaceFix Shoulder SpacerG21, S.R.L.K242216GENTAFIX® (1, 3, 3MV)Teknimed SasK240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbHK222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc.K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.K213287StageOne Knee Cement Spacer MoldsBiomet, 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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