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FDA 510(k)

THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX

K-Number: K040756 · 2004-07-14

ApplicantImplex Corp.
Decision Date2004-07-14
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 2004-07-14 under 510(k) number K040756. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX?

THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX is a medical device that received FDA 510(k) clearance on 2004-07-14. The listed applicant is Implex Corp.. The 510(k) number is K040756.

When did THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX receive FDA 510(k) clearance?

THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX received FDA 510(k) clearance on 2004-07-14, under 510(k) number K040756.

Who is the listed applicant for THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX?

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

What is the FDA product code for THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX?

The FDA product code for THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX is FTM.

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Other records listing Implex Corp. 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.

K051978TRABECULAR METAL VERTEBRAL BODY REPLACEMENTK051196TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1K040487TRABECULAR METAL KNEE SYSTEM AUGMENTSK040630TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZK031962NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTSK033384THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ

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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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