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)

OSTEO INTERLOCKING-COMPRESSION NAIL

K-Number: K933340 · 1994-06-30

ApplicantOsteo AG
Decision Date1994-06-30
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEO INTERLOCKING-COMPRESSION NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Osteo AG. It received FDA 510(k) clearance on 1994-06-30 under 510(k) number K933340. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEO INTERLOCKING-COMPRESSION NAIL?

OSTEO INTERLOCKING-COMPRESSION NAIL is a medical device that received FDA 510(k) clearance on 1994-06-30. The listed applicant is Osteo AG. The 510(k) number is K933340.

When did OSTEO INTERLOCKING-COMPRESSION NAIL receive FDA 510(k) clearance?

OSTEO INTERLOCKING-COMPRESSION NAIL received FDA 510(k) clearance on 1994-06-30, under 510(k) number K933340.

Who is the listed applicant for OSTEO INTERLOCKING-COMPRESSION NAIL?

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

What is the FDA product code for OSTEO INTERLOCKING-COMPRESSION NAIL?

The FDA product code for OSTEO INTERLOCKING-COMPRESSION NAIL is HSB.

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 Osteo AG 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.

K922193OSTEO KIRSCHNER WIREK922194OSTEO STEINMANN PINK922195OSTEO FEMORAL NAILK922196OSTEO TIBIA NAILK920149OSTEO EX-FI-REK920037OSTEO COMPRESSION HIP SCREW

View all 9 devices →

Related Devices (Code: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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.

↑