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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 a medical device manufactured by Renovo Life, LLC. It received FDA 510(k) clearance on 2016-11-07 under approval 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. It is manufactured by Renovo Life, LLC. The 510(k) number is K161254.

When was Renovo Life Small Bone IM Nail System approved by the FDA?

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

What company makes Renovo Life Small Bone IM Nail System?

Renovo Life Small Bone IM Nail System is manufactured by Renovo Life, LLC.

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.

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Other Devices by Renovo Life, LLC

K151661Renovo Life Hard Carbon Coated Drill Bit

Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated K160069Sonoma Fibula Repair SystemSonoma Orthopedics Products, 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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