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)

ORTHOTEC K-CAP SYSTEM

K-Number: K971453 · 1997-06-24

ApplicantOrthotech
Decision Date1997-06-24
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOTEC K-CAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthotech. It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K971453. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOTEC K-CAP SYSTEM?

ORTHOTEC K-CAP SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Orthotech. The 510(k) number is K971453.

When did ORTHOTEC K-CAP SYSTEM receive FDA 510(k) clearance?

ORTHOTEC K-CAP SYSTEM received FDA 510(k) clearance on 1997-06-24, under 510(k) number K971453.

Who is the listed applicant for ORTHOTEC K-CAP SYSTEM?

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

What is the FDA product code for ORTHOTEC K-CAP SYSTEM?

The FDA product code for ORTHOTEC K-CAP SYSTEM is HTY.

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 Orthotech 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.

K933080ORTHOTECH DURA-GOLD BARCKETS

Related Devices (Code: HTY)

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.

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

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.

↑