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)

Sonoma Fibula Repair System

K-Number: K160069 · 2016-03-10

ApplicantSonoma Orthopedics Products, Inc.
Decision Date2016-03-10
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sonoma Fibula Repair System is a medical device manufactured by Sonoma Orthopedics Products, Inc.. It received FDA 510(k) clearance on 2016-03-10 under approval number K160069. 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 Sonoma Fibula Repair System?

Sonoma Fibula Repair System is a medical device that received FDA 510(k) clearance on 2016-03-10. It is manufactured by Sonoma Orthopedics Products, Inc.. The 510(k) number is K160069.

When was Sonoma Fibula Repair System approved by the FDA?

Sonoma Fibula Repair System received FDA 510(k) clearance on 2016-03-10, under approval number K160069.

What company makes Sonoma Fibula Repair System?

Sonoma Fibula Repair System is manufactured by Sonoma Orthopedics Products, Inc..

What is the FDA product code for Sonoma Fibula Repair System?

The FDA product code for Sonoma Fibula Repair System is HSB.

Related Clinical Trials

NCT04097145 Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT04503395 ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES RECRUITING NCT03298477 EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study COMPLETED NCT06658730 Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance RECRUITING NCT03382457 Clinical Study of Edwards Cardioband FIT Valve Repair System ACTIVE_NOT_RECRUITING

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 K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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.

↑