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FDA 510(k)

HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ

K-Number: K010378 · 2002-01-28

ApplicantImplex Corp.
Decision Date2002-01-28
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 2002-01-28 under 510(k) number K010378. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ?

HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ is a medical device that received FDA 510(k) clearance on 2002-01-28. The listed applicant is Implex Corp.. The 510(k) number is K010378.

When did HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ receive FDA 510(k) clearance?

HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ received FDA 510(k) clearance on 2002-01-28, under 510(k) number K010378.

Who is the listed applicant for HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ?

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 HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ?

The FDA product code for HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ is MQP.

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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: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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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