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

FDA 510(k)

WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)

K-Number: K092110 · 2010-01-20

ApplicantSonoma Orthopedic Products, Inc.
Decision Date2010-01-20
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX) is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Orthopedic Products, Inc.. It received FDA 510(k) clearance on 2010-01-20 under 510(k) number K092110. 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 WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)?

WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX) is a medical device that received FDA 510(k) clearance on 2010-01-20. The listed applicant is Sonoma Orthopedic Products, Inc.. The 510(k) number is K092110.

When did WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX) receive FDA 510(k) clearance?

WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX) received FDA 510(k) clearance on 2010-01-20, under 510(k) number K092110.

Who is the listed applicant for WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)?

The FDA 510(k) record lists Sonoma Orthopedic Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)?

The FDA product code for WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX) is HSB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sonoma Orthopedic Products, 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.

K161371Sonoma Fifth Metatarsal Repair SystemK111550SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)K100112SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)K090304WAVEON WRX BONE FIXATION SYSTEMK081832ENSPLINTCMX CLAVICLE PINK080778ENSPLINT TM BONE SCREW

View all 8 devices →

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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.

↑