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)

ENSPLINTRX BONE FIXATION SYSTEM

K-Number: K071809 · 2008-02-21

ApplicantSonoma Orthopedic Products, Inc.
Decision Date2008-02-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENSPLINTRX BONE FIXATION SYSTEM 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 2008-02-21 under 510(k) number K071809. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENSPLINTRX BONE FIXATION SYSTEM?

ENSPLINTRX BONE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-02-21. The listed applicant is Sonoma Orthopedic Products, Inc.. The 510(k) number is K071809.

When did ENSPLINTRX BONE FIXATION SYSTEM receive FDA 510(k) clearance?

ENSPLINTRX BONE FIXATION SYSTEM received FDA 510(k) clearance on 2008-02-21, under 510(k) number K071809.

Who is the listed applicant for ENSPLINTRX BONE FIXATION SYSTEM?

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 ENSPLINTRX BONE FIXATION SYSTEM?

The FDA product code for ENSPLINTRX BONE FIXATION SYSTEM is HRS.

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)K092110WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)K090304WAVEON WRX BONE FIXATION SYSTEMK081832ENSPLINTCMX CLAVICLE PIN

View all 8 devices →

Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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.

↑