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)

OMEGA 3 TROCHANTERIC STABILIZING PLATE

K-Number: K081278 · 2008-05-29

ApplicantHowmedica Osteonics Corp.
Decision Date2008-05-29
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMEGA 3 TROCHANTERIC STABILIZING PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2008-05-29 under 510(k) number K081278. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMEGA 3 TROCHANTERIC STABILIZING PLATE?

OMEGA 3 TROCHANTERIC STABILIZING PLATE is a medical device that received FDA 510(k) clearance on 2008-05-29. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K081278.

When did OMEGA 3 TROCHANTERIC STABILIZING PLATE receive FDA 510(k) clearance?

OMEGA 3 TROCHANTERIC STABILIZING PLATE received FDA 510(k) clearance on 2008-05-29, under 510(k) number K081278.

Who is the listed applicant for OMEGA 3 TROCHANTERIC STABILIZING PLATE?

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

What is the FDA product code for OMEGA 3 TROCHANTERIC STABILIZING PLATE?

The FDA product code for OMEGA 3 TROCHANTERIC STABILIZING PLATE is KTT.

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 Howmedica Osteonics 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.

K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupK200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-ApatiteK130895REUNION RSA SHOULDER SYSTEMK123604ABG III MONOLITHIC HIP STEMK122015DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGEK123166TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P

View all 288 devices →

Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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.

↑