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FDA 510(k)

XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS

K-Number: K080928 · 2008-04-30

ApplicantStryker Spine
Decision Date2008-04-30
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Spine. It received FDA 510(k) clearance on 2008-04-30 under 510(k) number K080928. 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 XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS?

XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS is a medical device that received FDA 510(k) clearance on 2008-04-30. The listed applicant is Stryker Spine. The 510(k) number is K080928.

When did XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS receive FDA 510(k) clearance?

XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS received FDA 510(k) clearance on 2008-04-30, under 510(k) number K080928.

Who is the listed applicant for XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS?

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

What is the FDA product code for XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS?

The FDA product code for XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS is 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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