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FDA 510(k)

HARMONY PORT SYSTEM, MODEL 1907 SERIES

K-Number: K050706 · 2005-04-15

ApplicantSpinal Concepts, Inc.
Decision Date2005-04-15
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HARMONY PORT SYSTEM, MODEL 1907 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Concepts, Inc.. It received FDA 510(k) clearance on 2005-04-15 under 510(k) number K050706. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARMONY PORT SYSTEM, MODEL 1907 SERIES?

HARMONY PORT SYSTEM, MODEL 1907 SERIES is a medical device that received FDA 510(k) clearance on 2005-04-15. The listed applicant is Spinal Concepts, Inc.. The 510(k) number is K050706.

When did HARMONY PORT SYSTEM, MODEL 1907 SERIES receive FDA 510(k) clearance?

HARMONY PORT SYSTEM, MODEL 1907 SERIES received FDA 510(k) clearance on 2005-04-15, under 510(k) number K050706.

Who is the listed applicant for HARMONY PORT SYSTEM, MODEL 1907 SERIES?

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

What is the FDA product code for HARMONY PORT SYSTEM, MODEL 1907 SERIES?

The FDA product code for HARMONY PORT SYSTEM, MODEL 1907 SERIES is GZT.

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Other records listing Spinal Concepts, Inc. as applicant

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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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