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FDA 510(k)

StageOne Select Cement Spacer Molds for Temporary Hip Replacement

K-Number: K161166 · 2016-09-08

ApplicantBiomet, Inc.
Decision Date2016-09-08
Product CodeMBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

StageOne Select Cement Spacer Molds for Temporary Hip Replacement is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K161166. 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 Select Cement Spacer Molds for Temporary Hip Replacement?

StageOne Select Cement Spacer Molds for Temporary Hip Replacement is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Biomet, Inc.. The 510(k) number is K161166.

When did StageOne Select Cement Spacer Molds for Temporary Hip Replacement receive FDA 510(k) clearance?

StageOne Select Cement Spacer Molds for Temporary Hip Replacement received FDA 510(k) clearance on 2016-09-08, under 510(k) number K161166.

Who is the listed applicant for StageOne Select Cement Spacer Molds for Temporary Hip Replacement?

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 Select Cement Spacer Molds for Temporary Hip Replacement?

The FDA product code for StageOne Select Cement Spacer Molds for Temporary Hip Replacement is MBB.

Related Clinical Trials

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.

NCT06293352Real-component vs All-cement Articulating Spacers for Periprosthetic Knee InfectionRECRUITINGNCT07669376Role of Inferior Vena Cava Dispensability Index in Predicting Hypotension of Cement Syndrome in Hip Replacement Surgery Under General AnaesthesiaACTIVE_NOT_RECRUITING

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

View all 36 devices →

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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