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FDA 510(k)

MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280

K-Number: K071791 · 2007-07-30

ApplicantCodman & Shurtleff, Inc.
Decision Date2007-07-30
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2007-07-30 under 510(k) number K071791. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280?

MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 is a medical device that received FDA 510(k) clearance on 2007-07-30. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K071791.

When did MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 receive FDA 510(k) clearance?

MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 received FDA 510(k) clearance on 2007-07-30, under 510(k) number K071791.

Who is the listed applicant for MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280?

The FDA 510(k) record lists Codman & Shurtleff, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280?

The FDA product code for MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 is GXP.

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Related Devices (Code: GXP)

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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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