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FDA 510(k)

CERTEX OCT SPINAL IMPLANT SYSTEM

K-Number: K133094 · 2013-12-11

ApplicantX-Spine Systems, Inc.
Decision Date2013-12-11
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CERTEX OCT SPINAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2013-12-11 under 510(k) number K133094. 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 CERTEX OCT SPINAL IMPLANT SYSTEM?

CERTEX OCT SPINAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-11. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K133094.

When did CERTEX OCT SPINAL IMPLANT SYSTEM receive FDA 510(k) clearance?

CERTEX OCT SPINAL IMPLANT SYSTEM received FDA 510(k) clearance on 2013-12-11, under 510(k) number K133094.

Who is the listed applicant for CERTEX OCT SPINAL IMPLANT SYSTEM?

The FDA 510(k) record lists X-Spine Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERTEX OCT SPINAL IMPLANT SYSTEM?

The FDA product code for CERTEX OCT SPINAL IMPLANT SYSTEM is KWP.

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Other records listing X-Spine Systems, Inc. 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.

K173832InTice™-C Porous Ti Cervical Interbody SystemK180153X-spine Cortical Bone Screw SystemK170119Calix Lumbar Spinal Implant SystemK171567IRIX-A Lumbar Integrated Fusion SystemK171075Calix-C Cervical Interbody SpacerK170224Spider Cervical Plating System

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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.

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.K123906VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEMMedtronic Sofamor Danek USA, 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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