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FDA 510(k)

ZUMA, MODEL 55-XXXX/56-XXXX

K-Number: K082926 · 2008-12-22

ApplicantSeaspine, Inc.
Decision Date2008-12-22
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZUMA, MODEL 55-XXXX/56-XXXX is the device name listed in this FDA 510(k) record. The listed applicant is Seaspine, Inc.. It received FDA 510(k) clearance on 2008-12-22 under 510(k) number K082926. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZUMA, MODEL 55-XXXX/56-XXXX?

ZUMA, MODEL 55-XXXX/56-XXXX is a medical device that received FDA 510(k) clearance on 2008-12-22. The listed applicant is Seaspine, Inc.. The 510(k) number is K082926.

When did ZUMA, MODEL 55-XXXX/56-XXXX receive FDA 510(k) clearance?

ZUMA, MODEL 55-XXXX/56-XXXX received FDA 510(k) clearance on 2008-12-22, under 510(k) number K082926.

Who is the listed applicant for ZUMA, MODEL 55-XXXX/56-XXXX?

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

What is the FDA product code for ZUMA, MODEL 55-XXXX/56-XXXX?

The FDA product code for ZUMA, MODEL 55-XXXX/56-XXXX is OVD.

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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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