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FDA 510(k)

ZUMA-C

K-Number: K092521 · 2010-04-13

ApplicantSeaspine, Inc.
Decision Date2010-04-13
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZUMA-C is the device name listed in this FDA 510(k) record. The listed applicant is Seaspine, Inc.. It received FDA 510(k) clearance on 2010-04-13 under 510(k) number K092521. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZUMA-C?

ZUMA-C is a medical device that received FDA 510(k) clearance on 2010-04-13. The listed applicant is Seaspine, Inc.. The 510(k) number is K092521.

When did ZUMA-C receive FDA 510(k) clearance?

ZUMA-C received FDA 510(k) clearance on 2010-04-13, under 510(k) number K092521.

Who is the listed applicant for ZUMA-C?

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-C?

The FDA product code for ZUMA-C is OVE.

Other records listing Seaspine, Inc. as applicant

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Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K263049SABER-C SystemElevation SpineK261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLCK261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.

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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