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)

SYNTHES (USA) TIBIAL NAIL SYSTEM EX

K-Number: K040762 · 2004-04-12

ApplicantSynthes (Usa)
Decision Date2004-04-12
Product CodeJDS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) TIBIAL NAIL SYSTEM EX is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2004-04-12 under 510(k) number K040762. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES (USA) TIBIAL NAIL SYSTEM EX?

SYNTHES (USA) TIBIAL NAIL SYSTEM EX is a medical device that received FDA 510(k) clearance on 2004-04-12. The listed applicant is Synthes (Usa). The 510(k) number is K040762.

When did SYNTHES (USA) TIBIAL NAIL SYSTEM EX receive FDA 510(k) clearance?

SYNTHES (USA) TIBIAL NAIL SYSTEM EX received FDA 510(k) clearance on 2004-04-12, under 510(k) number K040762.

Who is the listed applicant for SYNTHES (USA) TIBIAL NAIL SYSTEM EX?

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

What is the FDA product code for SYNTHES (USA) TIBIAL NAIL SYSTEM EX?

The FDA product code for SYNTHES (USA) TIBIAL NAIL SYSTEM EX is JDS.

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 Synthes (Usa) 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.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

View all 409 devices →

Related Devices (Code: JDS)

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.

K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc.K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc.K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical , Ltd.K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmSynthes (USA) Products, LLC

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.

↑