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FDA 510(k)

NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY

K-Number: K102018 · 2010-09-23

ApplicantSynthes USA Products, LLC
Decision Date2010-09-23
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY is the device name listed in this FDA 510(k) record. The listed applicant is Synthes USA Products, LLC. It received FDA 510(k) clearance on 2010-09-23 under 510(k) number K102018. 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 NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY?

NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY is a medical device that received FDA 510(k) clearance on 2010-09-23. The listed applicant is Synthes USA Products, LLC. The 510(k) number is K102018.

When did NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY receive FDA 510(k) clearance?

NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY received FDA 510(k) clearance on 2010-09-23, under 510(k) number K102018.

Who is the listed applicant for NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY?

The FDA 510(k) record lists Synthes USA Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY?

The FDA product code for NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY 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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