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FDA 510(k)

StageOne™ Shoulder Cement Spacer Molds

K-Number: K221968 · 2022-09-15

ApplicantBiomet, Inc.
Decision Date2022-09-15
Product CodeMBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

StageOne™ Shoulder Cement Spacer Molds is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2022-09-15 under 510(k) number K221968. 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™ Shoulder Cement Spacer Molds?

StageOne™ Shoulder Cement Spacer Molds is a medical device that received FDA 510(k) clearance on 2022-09-15. The listed applicant is Biomet, Inc.. The 510(k) number is K221968.

When did StageOne™ Shoulder Cement Spacer Molds receive FDA 510(k) clearance?

StageOne™ Shoulder Cement Spacer Molds received FDA 510(k) clearance on 2022-09-15, under 510(k) number K221968.

Who is the listed applicant for StageOne™ Shoulder Cement Spacer Molds?

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™ Shoulder Cement Spacer Molds?

The FDA product code for StageOne™ Shoulder Cement Spacer Molds 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 MoldsK213287StageOne Knee Cement Spacer MoldsK212431Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve

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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.K213287StageOne Knee Cement Spacer MoldsBiomet, Inc.K202338SpaceFlex ShoulderG21, S.R.L.

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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