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)

OMNI-FIX, HUMERAL NAIL

K-Number: K991405 · 1999-06-29

ApplicantTurnkey Intergration USA, Inc.
Decision Date1999-06-29
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMNI-FIX, HUMERAL NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Turnkey Intergration USA, Inc.. It received FDA 510(k) clearance on 1999-06-29 under 510(k) number K991405. The device is classified under product code KTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI-FIX, HUMERAL NAIL?

OMNI-FIX, HUMERAL NAIL is a medical device that received FDA 510(k) clearance on 1999-06-29. The listed applicant is Turnkey Intergration USA, Inc.. The 510(k) number is K991405.

When did OMNI-FIX, HUMERAL NAIL receive FDA 510(k) clearance?

OMNI-FIX, HUMERAL NAIL received FDA 510(k) clearance on 1999-06-29, under 510(k) number K991405.

Who is the listed applicant for OMNI-FIX, HUMERAL NAIL?

The FDA 510(k) record lists Turnkey Intergration USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNI-FIX, HUMERAL NAIL?

The FDA product code for OMNI-FIX, HUMERAL NAIL is KTW.

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 Turnkey Intergration USA, 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.

K990523B2C, ESPACE REVISION CUP SYSTEMK990307OMNI-FIX, NAIL SYSTEMK972411LINK CEMENT PLUGK970284ARTOS, DIPLOS SYSTEMK970084LINK CERCLAGE WIRE SYSTEMK953653LUBINUS SP II HIP SYSTEM

View all 26 devices →

Related Devices (Code: KTW)

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.

K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd.K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos)K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.K160409AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc.K122541ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)Orthofix SrlK080590AOS PROXIMAL HUMERAL PLATEAdvanced Orthopaedic Solutions, Inc.

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.

↑