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)

LEVTECH SMALL BONE PLATE

K-Number: K893928 · 1989-11-03

ApplicantBuckman Co., Inc.
Decision Date1989-11-03
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LEVTECH SMALL BONE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Buckman Co., Inc.. It received FDA 510(k) clearance on 1989-11-03 under 510(k) number K893928. 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 LEVTECH SMALL BONE PLATE?

LEVTECH SMALL BONE PLATE is a medical device that received FDA 510(k) clearance on 1989-11-03. The listed applicant is Buckman Co., Inc.. The 510(k) number is K893928.

When did LEVTECH SMALL BONE PLATE receive FDA 510(k) clearance?

LEVTECH SMALL BONE PLATE received FDA 510(k) clearance on 1989-11-03, under 510(k) number K893928.

Who is the listed applicant for LEVTECH SMALL BONE PLATE?

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

What is the FDA product code for LEVTECH SMALL BONE PLATE?

The FDA product code for LEVTECH SMALL BONE PLATE 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 Buckman Co., 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.

K961320CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEMK974641FUTURELASE 3000/3002 ERBIUM LASER SYSTEMK964252ORTHOCHUCKK950099SYNERGY(TM) TI POSTERIOR SPINAL SYSTEMK960451WEBB-MORLEY SPINE SYSTEMK950999KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS

View all 111 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.

↑