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FDA 510(k)

TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000

K-Number: K862579 · 1986-08-06

ApplicantTru-Trac
Decision Date1986-08-06
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000 is the device name listed in this FDA 510(k) record. The listed applicant is Tru-Trac. It received FDA 510(k) clearance on 1986-08-06 under 510(k) number K862579. 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 TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000?

TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000 is a medical device that received FDA 510(k) clearance on 1986-08-06. The listed applicant is Tru-Trac. The 510(k) number is K862579.

When did TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000 receive FDA 510(k) clearance?

TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000 received FDA 510(k) clearance on 1986-08-06, under 510(k) number K862579.

Who is the listed applicant for TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000?

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

What is the FDA product code for TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000?

The FDA product code for TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000 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.

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Other records listing Tru-Trac 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.

K893448TRU TRAC TRACTION TABLEK862780TRU-KINETICS (TM)

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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