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FDA 510(k)

EXTENTRAC ELITE

K-Number: K031996 · 2004-07-23

ApplicantAdvanced Back Technologies
Decision Date2004-07-23
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EXTENTRAC ELITE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Back Technologies. It received FDA 510(k) clearance on 2004-07-23 under 510(k) number K031996. 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 EXTENTRAC ELITE?

EXTENTRAC ELITE is a medical device that received FDA 510(k) clearance on 2004-07-23. The listed applicant is Advanced Back Technologies. The 510(k) number is K031996.

When did EXTENTRAC ELITE receive FDA 510(k) clearance?

EXTENTRAC ELITE received FDA 510(k) clearance on 2004-07-23, under 510(k) number K031996.

Who is the listed applicant for EXTENTRAC ELITE?

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

What is the FDA product code for EXTENTRAC ELITE?

The FDA product code for EXTENTRAC ELITE 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 Advanced Back Technologies 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.

K980021EXTENTRAC

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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