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FDA 510(k)

EBI ESL PEEK-OPTIMA SPINE SYSTEM

K-Number: K061016 · 2006-06-08

ApplicantEbi, L.P.
Decision Date2006-06-08
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EBI ESL PEEK-OPTIMA SPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ebi, L.P.. It received FDA 510(k) clearance on 2006-06-08 under 510(k) number K061016. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBI ESL PEEK-OPTIMA SPINE SYSTEM?

EBI ESL PEEK-OPTIMA SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-06-08. The listed applicant is Ebi, L.P.. The 510(k) number is K061016.

When did EBI ESL PEEK-OPTIMA SPINE SYSTEM receive FDA 510(k) clearance?

EBI ESL PEEK-OPTIMA SPINE SYSTEM received FDA 510(k) clearance on 2006-06-08, under 510(k) number K061016.

Who is the listed applicant for EBI ESL PEEK-OPTIMA SPINE SYSTEM?

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

What is the FDA product code for EBI ESL PEEK-OPTIMA SPINE SYSTEM?

The FDA product code for EBI ESL PEEK-OPTIMA SPINE SYSTEM is MQP.

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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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