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FDA 510(k)

SYNSPAR ADVANCED

K-Number: K123613 · 2013-02-20

ApplicantArdent, Inc.
Decision Date2013-02-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNSPAR ADVANCED is the device name listed in this FDA 510(k) record. The listed applicant is Ardent, Inc.. It received FDA 510(k) clearance on 2013-02-20 under 510(k) number K123613. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNSPAR ADVANCED?

SYNSPAR ADVANCED is a medical device that received FDA 510(k) clearance on 2013-02-20. The listed applicant is Ardent, Inc.. The 510(k) number is K123613.

When did SYNSPAR ADVANCED receive FDA 510(k) clearance?

SYNSPAR ADVANCED received FDA 510(k) clearance on 2013-02-20, under 510(k) number K123613.

Who is the listed applicant for SYNSPAR ADVANCED?

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

What is the FDA product code for SYNSPAR ADVANCED?

The FDA product code for SYNSPAR ADVANCED is EIH.

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Related Devices (Code: EIH)

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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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