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FDA 510(k)

TURBO PRIME IBD SYSTEM

K-Number: K080058 · 2008-04-16

ApplicantSpineselect, LLC
Decision Date2008-04-16
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TURBO PRIME IBD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spineselect, LLC. It received FDA 510(k) clearance on 2008-04-16 under 510(k) number K080058. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TURBO PRIME IBD SYSTEM?

TURBO PRIME IBD SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-16. The listed applicant is Spineselect, LLC. The 510(k) number is K080058.

When did TURBO PRIME IBD SYSTEM receive FDA 510(k) clearance?

TURBO PRIME IBD SYSTEM received FDA 510(k) clearance on 2008-04-16, under 510(k) number K080058.

Who is the listed applicant for TURBO PRIME IBD SYSTEM?

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

What is the FDA product code for TURBO PRIME IBD SYSTEM?

The FDA product code for TURBO PRIME IBD SYSTEM is MAX.

Related Clinical Trials

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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