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FDA 510(k)

Spinal Elements Ti-Bond coated devices

K-Number: K181837 · 2018-11-02

ApplicantSpinal Elements, Inc.
Decision Date2018-11-02
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spinal Elements Ti-Bond coated devices 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 2018-11-02 under 510(k) number K181837. 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 Spinal Elements Ti-Bond coated devices?

Spinal Elements Ti-Bond coated devices is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K181837.

When did Spinal Elements Ti-Bond coated devices receive FDA 510(k) clearance?

Spinal Elements Ti-Bond coated devices received FDA 510(k) clearance on 2018-11-02, under 510(k) number K181837.

Who is the listed applicant for Spinal Elements Ti-Bond coated devices?

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 Ti-Bond coated devices?

The FDA product code for Spinal Elements Ti-Bond coated devices is MAX.

Other records listing Spinal Elements, Inc. as applicant

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Related Devices (Code: MAX)

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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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