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FDA 510(k)

OTELO LL

K-Number: K151104 · 2016-01-06

ApplicantSpineart
Decision Date2016-01-06
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OTELO LL is a medical device manufactured by Spineart. It received FDA 510(k) clearance on 2016-01-06 under approval number K151104. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTELO LL?

OTELO LL is a medical device that received FDA 510(k) clearance on 2016-01-06. It is manufactured by Spineart. The 510(k) number is K151104.

When was OTELO LL approved by the FDA?

OTELO LL received FDA 510(k) clearance on 2016-01-06, under approval number K151104.

What company makes OTELO LL?

OTELO LL is manufactured by Spineart.

What is the FDA product code for OTELO LL?

The FDA product code for OTELO LL is GAD.

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Related Devices (Code: GAD)

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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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