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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 the device name listed in this FDA 510(k) record. The listed applicant is Osartis GmbH. It received FDA 510(k) clearance on 2024-11-20 under 510(k) 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. The listed applicant is Osartis GmbH. The 510(k) number is K240856.

When did Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds receive FDA 510(k) clearance?

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

Who is the listed applicant for Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds?

The FDA 510(k) record lists Osartis GmbH as the applicant. This does not by itself establish the device manufacturer.

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.

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.

NCT05038709Positioning for Hip Arthroscopic Surgery to Reduce Postoperative NumbnessACTIVE_NOT_RECRUITINGNCT07563803The restor3d Outcomes RegistryNOT_YET_RECRUITING

Other records listing Osartis GmbH 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.

K202458BonOs Inject, Pedicle screw kits, Cement pusherK210125BonOs HV Genta, BonOs MV Genta, BonOs LV GentaK210120BonOs HV, BonOs MV, BonOs LVK192394Hi-Fatigue Bone CementK192379Hi-Fatigue G Bone Cement

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 SasK222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc.K221968StageOne™ Shoulder 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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