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FDA 510(k)

MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT

K-Number: K110684 · 2011-06-24

ApplicantVanduzen Dba Medcad
Decision Date2011-06-24
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Vanduzen Dba Medcad. It received FDA 510(k) clearance on 2011-06-24 under 510(k) number K110684. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT?

MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT is a medical device that received FDA 510(k) clearance on 2011-06-24. The listed applicant is Vanduzen Dba Medcad. The 510(k) number is K110684.

When did MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT receive FDA 510(k) clearance?

MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT received FDA 510(k) clearance on 2011-06-24, under 510(k) number K110684.

Who is the listed applicant for MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT?

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

What is the FDA product code for MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT?

The FDA product code for MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT is GXN.

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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: GXN)

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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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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