Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PRECICE Intramedullary Limb Lengthening System

K-Number: K160325 · 2016-04-04

ApplicantEllipse Technologies, Inc.
Decision Date2016-04-04
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRECICE Intramedullary Limb Lengthening System is a medical device manufactured by Ellipse Technologies, Inc.. It received FDA 510(k) clearance on 2016-04-04 under approval number K160325. 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 PRECICE Intramedullary Limb Lengthening System?

PRECICE Intramedullary Limb Lengthening System is a medical device that received FDA 510(k) clearance on 2016-04-04. It is manufactured by Ellipse Technologies, Inc.. The 510(k) number is K160325.

When was PRECICE Intramedullary Limb Lengthening System approved by the FDA?

PRECICE Intramedullary Limb Lengthening System received FDA 510(k) clearance on 2016-04-04, under approval number K160325.

What company makes PRECICE Intramedullary Limb Lengthening System?

PRECICE Intramedullary Limb Lengthening System is manufactured by Ellipse Technologies, Inc..

What is the FDA product code for PRECICE Intramedullary Limb Lengthening System?

The FDA product code for PRECICE Intramedullary Limb Lengthening System is HSB.

Related Clinical Trials

NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT07569575 Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures NOT_YET_RECRUITING NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT06400732 Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System TERMINATED

Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC 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.

↑