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FDA 510(k)

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds

K-Number: K240856 · 2024-11-20

ApplicantOsartis GmbH
Decision Date2024-11-20
Product CodeMBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds is a medical device manufactured by Osartis GmbH. It received FDA 510(k) clearance on 2024-11-20 under approval number K240856. 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 Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds?

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds is a medical device that received FDA 510(k) clearance on 2024-11-20. It is manufactured by Osartis GmbH. The 510(k) number is K240856.

When was Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds approved by the FDA?

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds received FDA 510(k) clearance on 2024-11-20, under approval number K240856.

What company makes Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds?

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds is manufactured by Osartis GmbH.

What is the FDA product code for Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds?

The FDA product code for Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds is MBB.

Other Devices by Osartis GmbH

K192394Hi-Fatigue Bone Cement K192379Hi-Fatigue G Bone Cement K202458BonOs Inject, Pedicle screw kits, Cement pusher K210120BonOs HV, BonOs MV, BonOs LV K210125BonOs HV Genta, BonOs MV Genta, BonOs LV Genta

Related Devices (Code: MBB)

K161166StageOne Select Cement Spacer Molds for Temporary Hip ReplacementBiomet, Inc. K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc. K161273StageOne Disposable Cement Spacer Molds for Temporary Knee ProsthesisBiomet, Inc. K192041G21 SpaceFlex HipG21, S.R.L. K190216SpaceFlex KneeG21, S.R.L. K201960SpaceFlex Knee - 80mm SizeG21, 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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