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FDA 510(k)

Comprehensive Humeral Fracture Positioning Sleeves

K-Number: K212435 · 2021-12-10

ApplicantBiomet, Inc.
Decision Date2021-12-10
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Comprehensive Humeral Fracture Positioning Sleeves is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2021-12-10 under approval number K212435. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Comprehensive Humeral Fracture Positioning Sleeves?

Comprehensive Humeral Fracture Positioning Sleeves is a medical device that received FDA 510(k) clearance on 2021-12-10. It is manufactured by Biomet, Inc.. The 510(k) number is K212435.

When was Comprehensive Humeral Fracture Positioning Sleeves approved by the FDA?

Comprehensive Humeral Fracture Positioning Sleeves received FDA 510(k) clearance on 2021-12-10, under approval number K212435.

What company makes Comprehensive Humeral Fracture Positioning Sleeves?

Comprehensive Humeral Fracture Positioning Sleeves is manufactured by Biomet, Inc..

What is the FDA product code for Comprehensive Humeral Fracture Positioning Sleeves?

The FDA product code for Comprehensive Humeral Fracture Positioning Sleeves is KWS.

Related Clinical Trials

NCT06911385 Augmenting Cerebral Blood Flow in Acute Ischemic Stroke NOT_YET_RECRUITING NCT05773352 Perform® Humeral System - Fracture Study (PFX) ACTIVE_NOT_RECRUITING

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Related Devices (Code: KWS)

K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)Stryker GmbH K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. K161108Arthrex VaultLock GlenoidArthrex, Inc. K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.

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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