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FDA 510(k)

TRACTION SYSTEM, DIGIT-TRAC 930

K-Number: K052453 · 2006-01-13

ApplicantEver Prosperous Instrument, Inc.
Decision Date2006-01-13
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TRACTION SYSTEM, DIGIT-TRAC 930 is the device name listed in this FDA 510(k) record. The listed applicant is Ever Prosperous Instrument, Inc.. It received FDA 510(k) clearance on 2006-01-13 under 510(k) number K052453. 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 TRACTION SYSTEM, DIGIT-TRAC 930?

TRACTION SYSTEM, DIGIT-TRAC 930 is a medical device that received FDA 510(k) clearance on 2006-01-13. The listed applicant is Ever Prosperous Instrument, Inc.. The 510(k) number is K052453.

When did TRACTION SYSTEM, DIGIT-TRAC 930 receive FDA 510(k) clearance?

TRACTION SYSTEM, DIGIT-TRAC 930 received FDA 510(k) clearance on 2006-01-13, under 510(k) number K052453.

Who is the listed applicant for TRACTION SYSTEM, DIGIT-TRAC 930?

The FDA 510(k) record lists Ever Prosperous Instrument, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACTION SYSTEM, DIGIT-TRAC 930?

The FDA product code for TRACTION SYSTEM, DIGIT-TRAC 930 is ITH.

Related Clinical Trials

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Other records listing Ever Prosperous Instrument, Inc. 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.

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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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