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FDA 510(k)

LTD POLYAXIAL FIXATION SYSTEM

K-Number: K041625 · 2004-09-08

ApplicantUs Spinal Technologies, LLC
Decision Date2004-09-08
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LTD POLYAXIAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Us Spinal Technologies, LLC. It received FDA 510(k) clearance on 2004-09-08 under 510(k) number K041625. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LTD POLYAXIAL FIXATION SYSTEM?

LTD POLYAXIAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-08. The listed applicant is Us Spinal Technologies, LLC. The 510(k) number is K041625.

When did LTD POLYAXIAL FIXATION SYSTEM receive FDA 510(k) clearance?

LTD POLYAXIAL FIXATION SYSTEM received FDA 510(k) clearance on 2004-09-08, under 510(k) number K041625.

Who is the listed applicant for LTD POLYAXIAL FIXATION SYSTEM?

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

What is the FDA product code for LTD POLYAXIAL FIXATION SYSTEM?

The FDA product code for LTD POLYAXIAL FIXATION SYSTEM is KWQ.

Related Clinical Trials

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Other records listing Us Spinal Technologies, LLC as applicant

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.

K041798ATALIA TITANIUM SURGICAL MESH

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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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