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)

3D ACTIVETRAC

K-Number: K001712 · 2000-08-31

ApplicantThe Saunders Group
Decision Date2000-08-31
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

3D ACTIVETRAC is the device name listed in this FDA 510(k) record. The listed applicant is The Saunders Group. It received FDA 510(k) clearance on 2000-08-31 under 510(k) number K001712. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D ACTIVETRAC?

3D ACTIVETRAC is a medical device that received FDA 510(k) clearance on 2000-08-31. The listed applicant is The Saunders Group. The 510(k) number is K001712.

When did 3D ACTIVETRAC receive FDA 510(k) clearance?

3D ACTIVETRAC received FDA 510(k) clearance on 2000-08-31, under 510(k) number K001712.

Who is the listed applicant for 3D ACTIVETRAC?

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

What is the FDA product code for 3D ACTIVETRAC?

The FDA product code for 3D ACTIVETRAC is ITH.

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 The Saunders Group 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.

K943898SAUNDERS ELECTRONIC INCLINOMETER

Related Devices (Code: ITH)

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.

K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLCK243366DRX9000C-SL Cervical Spinal Decompression SystemExcite Medical of Tampa Bay, LLCK214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLCK222912c1TracZimmer Medizinsysteme GmbHK112074EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800Everyway Medical Instruments Co.,LtdK103248INTEGRITY SPINAL CARE SYSTEMIntegra Life Sciences

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.

↑