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FDA 510(k)

MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM

K-Number: K032282 · 2003-08-21

ApplicantImplex Corp.
Decision Date2003-08-21
Product CodeEZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 2003-08-21 under 510(k) number K032282. The device is classified under product code EZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM?

MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-08-21. The listed applicant is Implex Corp.. The 510(k) number is K032282.

When did MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM received FDA 510(k) clearance on 2003-08-21, under 510(k) number K032282.

Who is the listed applicant for MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM?

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 MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM?

The FDA product code for MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM is EZX.

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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-ZZZZK040756THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXXK031962NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS

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Related Devices (Code: EZX)

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.

K063461ANOVA CONTAINMENT DEVICEAnova CorporationK014200OPTIMESHSpineology, Inc.K032344THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330Implex Corp.K024169MACROPORE OS RECONSTRUCTIONMacropore Biosurgery, Inc.K023882THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEMImplex Corp.K020853NUVASIVE MESHNuvasive, Inc.

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.

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