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)

SYNTEC OSTEO-PLATE AND SCREW FIXATION

K-Number: K092889 · 2010-06-25

ApplicantSyntec Scientific Corp.
Decision Date2010-06-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTEC OSTEO-PLATE AND SCREW FIXATION is the device name listed in this FDA 510(k) record. The listed applicant is Syntec Scientific Corp.. It received FDA 510(k) clearance on 2010-06-25 under 510(k) number K092889. 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 SYNTEC OSTEO-PLATE AND SCREW FIXATION?

SYNTEC OSTEO-PLATE AND SCREW FIXATION is a medical device that received FDA 510(k) clearance on 2010-06-25. The listed applicant is Syntec Scientific Corp.. The 510(k) number is K092889.

When did SYNTEC OSTEO-PLATE AND SCREW FIXATION receive FDA 510(k) clearance?

SYNTEC OSTEO-PLATE AND SCREW FIXATION received FDA 510(k) clearance on 2010-06-25, under 510(k) number K092889.

Who is the listed applicant for SYNTEC OSTEO-PLATE AND SCREW FIXATION?

The FDA 510(k) record lists Syntec Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTEC OSTEO-PLATE AND SCREW FIXATION?

The FDA product code for SYNTEC OSTEO-PLATE AND SCREW FIXATION 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 Syntec Scientific Corp. 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.

K111189SYNTEC DENTAL IMPLANTK101971SYNTEC OS SPINAL FIXATION SYSTEMK090476SYNTEC ORTHODONTIC MINI SCREWK090839MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTSK984602SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEMK984364SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820

View all 13 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.

↑