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FDA 510(k)

Renovo Life Small Bone IM Nail System

K-Number: K161254 · 2016-11-07

ApplicantRenovo Life, LLC
Decision Date2016-11-07
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Renovo Life Small Bone IM Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Renovo Life, LLC. It received FDA 510(k) clearance on 2016-11-07 under 510(k) number K161254. 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 Renovo Life Small Bone IM Nail System?

Renovo Life Small Bone IM Nail System is a medical device that received FDA 510(k) clearance on 2016-11-07. The listed applicant is Renovo Life, LLC. The 510(k) number is K161254.

When did Renovo Life Small Bone IM Nail System receive FDA 510(k) clearance?

Renovo Life Small Bone IM Nail System received FDA 510(k) clearance on 2016-11-07, under 510(k) number K161254.

Who is the listed applicant for Renovo Life Small Bone IM Nail System?

The FDA 510(k) record lists Renovo Life, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Renovo Life Small Bone IM Nail System?

The FDA product code for Renovo Life Small Bone IM Nail System is HSB.

Other records listing Renovo Life, LLC 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.

K151661Renovo Life Hard Carbon Coated Drill Bit

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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