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FDA 510(k)

Seneka II Polyscrew Pedicle Fixation System

K-Number: K153525 · 2016-01-28

ApplicantSenecka Spine
Decision Date2016-01-28
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Seneka II Polyscrew Pedicle Fixation System is a medical device manufactured by Senecka Spine. It received FDA 510(k) clearance on 2016-01-28 under approval number K153525. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Seneka II Polyscrew Pedicle Fixation System?

Seneka II Polyscrew Pedicle Fixation System is a medical device that received FDA 510(k) clearance on 2016-01-28. It is manufactured by Senecka Spine. The 510(k) number is K153525.

When was Seneka II Polyscrew Pedicle Fixation System approved by the FDA?

Seneka II Polyscrew Pedicle Fixation System received FDA 510(k) clearance on 2016-01-28, under approval number K153525.

What company makes Seneka II Polyscrew Pedicle Fixation System?

Seneka II Polyscrew Pedicle Fixation System is manufactured by Senecka Spine.

What is the FDA product code for Seneka II Polyscrew Pedicle Fixation System?

The FDA product code for Seneka II Polyscrew Pedicle Fixation System is NKB.

Related Clinical Trials

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Related Devices (Code: NKB)

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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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