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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 the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2021-12-10 under 510(k) 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. The listed applicant is Biomet, Inc.. The 510(k) number is K212435.

When did Comprehensive Humeral Fracture Positioning Sleeves receive FDA 510(k) clearance?

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

Who is the listed applicant for Comprehensive Humeral Fracture Positioning Sleeves?

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 Comprehensive Humeral Fracture Positioning Sleeves?

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

Other records listing Biomet, Inc. as applicant

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Related Devices (Code: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, 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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