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FDA 510(k)

LTD POLYAXIAL FIXATION SYSTEM

K-Number: K062785 · 2006-12-26

ApplicantUs Spine
Decision Date2006-12-26
Product CodeKWP
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 Spine. It received FDA 510(k) clearance on 2006-12-26 under 510(k) number K062785. The device is classified under product code KWP. 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 2006-12-26. The listed applicant is Us Spine. The 510(k) number is K062785.

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

LTD POLYAXIAL FIXATION SYSTEM received FDA 510(k) clearance on 2006-12-26, under 510(k) number K062785.

Who is the listed applicant for LTD POLYAXIAL FIXATION SYSTEM?

The FDA 510(k) record lists Us Spine 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 KWP.

Related Clinical Trials

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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Other records listing Us Spine 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.

K082801PHANTOM PLUS CAGE SYSTEMK081883MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEMK081296PREFERENCE PEDICLE SCREW SYSTEMK061041US SPINE FACET FIXATION SYSTEM

Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

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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