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FDA 510(k)

Affixus Hip Fracture Nail

K-Number: K183162 · 2018-12-14

ApplicantBiomet, Inc.
Decision Date2018-12-14
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Affixus Hip Fracture Nail is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K183162. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Affixus Hip Fracture Nail?

Affixus Hip Fracture Nail is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Biomet, Inc.. The 510(k) number is K183162.

When did Affixus Hip Fracture Nail receive FDA 510(k) clearance?

Affixus Hip Fracture Nail received FDA 510(k) clearance on 2018-12-14, under 510(k) number K183162.

Who is the listed applicant for Affixus Hip Fracture Nail?

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 Affixus Hip Fracture Nail?

The FDA product code for Affixus Hip Fracture Nail is HSB.

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.

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Related Devices (Code: HSB)

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.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

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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