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FDA 510(k)

ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM

K-Number: K110963 · 2011-05-05

ApplicantGlobus Medical, Inc.
Decision Date2011-05-05
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2011-05-05 under 510(k) number K110963. 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 ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM?

ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-05. The listed applicant is Globus Medical, Inc.. The 510(k) number is K110963.

When did ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM receive FDA 510(k) clearance?

ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM received FDA 510(k) clearance on 2011-05-05, under 510(k) number K110963.

Who is the listed applicant for ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM?

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

What is the FDA product code for ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM?

The FDA product code for ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM is KWP.

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Related Devices (Code: KWP)

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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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