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FDA 510(k)

MODIFICATION TO COLORADO 2 SPINAL SYSTEM

K-Number: K030875 · 2003-06-24

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2003-06-24
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO COLORADO 2 SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek, Inc.. It received FDA 510(k) clearance on 2003-06-24 under 510(k) number K030875. 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 MODIFICATION TO COLORADO 2 SPINAL SYSTEM?

MODIFICATION TO COLORADO 2 SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2003-06-24. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K030875.

When did MODIFICATION TO COLORADO 2 SPINAL SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO COLORADO 2 SPINAL SYSTEM received FDA 510(k) clearance on 2003-06-24, under 510(k) number K030875.

Who is the listed applicant for MODIFICATION TO COLORADO 2 SPINAL SYSTEM?

The FDA 510(k) record lists Medtronic Sofamor Danek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO COLORADO 2 SPINAL SYSTEM?

The FDA product code for MODIFICATION TO COLORADO 2 SPINAL SYSTEM is KWP.

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Related Devices (Code: KWP)

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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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