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FDA 510(k)

SECURIS SPINAL FIXATION

K-Number: K113361 · 2012-04-03

ApplicantCumtom Spine
Decision Date2012-04-03
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SECURIS SPINAL FIXATION is the device name listed in this FDA 510(k) record. The listed applicant is Cumtom Spine. It received FDA 510(k) clearance on 2012-04-03 under 510(k) number K113361. 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 SECURIS SPINAL FIXATION?

SECURIS SPINAL FIXATION is a medical device that received FDA 510(k) clearance on 2012-04-03. The listed applicant is Cumtom Spine. The 510(k) number is K113361.

When did SECURIS SPINAL FIXATION receive FDA 510(k) clearance?

SECURIS SPINAL FIXATION received FDA 510(k) clearance on 2012-04-03, under 510(k) number K113361.

Who is the listed applicant for SECURIS SPINAL FIXATION?

The FDA 510(k) record lists Cumtom Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SECURIS SPINAL FIXATION?

The FDA product code for SECURIS SPINAL FIXATION is NKB.

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Related Devices (Code: NKB)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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