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FDA 510(k)

Spinal Elements' Spinous Process Plate System

K-Number: K160465 · 2016-07-28

ApplicantSpinal Elements, Inc.
Decision Date2016-07-28
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spinal Elements' Spinous Process Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K160465. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spinal Elements' Spinous Process Plate System?

Spinal Elements' Spinous Process Plate System is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K160465.

When did Spinal Elements' Spinous Process Plate System receive FDA 510(k) clearance?

Spinal Elements' Spinous Process Plate System received FDA 510(k) clearance on 2016-07-28, under 510(k) number K160465.

Who is the listed applicant for Spinal Elements' Spinous Process Plate System?

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

What is the FDA product code for Spinal Elements' Spinous Process Plate System?

The FDA product code for Spinal Elements' Spinous Process Plate System is PEK.

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Related Devices (Code: PEK)

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.

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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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