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FDA 510(k)

SP-FIX SPINOUS PROCESS FIXATION PLATE

K-Number: K102195 · 2011-01-19

ApplicantGlobus Medical, Inc.
Decision Date2011-01-19
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SP-FIX SPINOUS PROCESS FIXATION PLATE 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 2011-01-19 under 510(k) number K102195. 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 SP-FIX SPINOUS PROCESS FIXATION PLATE?

SP-FIX SPINOUS PROCESS FIXATION PLATE is a medical device that received FDA 510(k) clearance on 2011-01-19. The listed applicant is Globus Medical, Inc.. The 510(k) number is K102195.

When did SP-FIX SPINOUS PROCESS FIXATION PLATE receive FDA 510(k) clearance?

SP-FIX SPINOUS PROCESS FIXATION PLATE received FDA 510(k) clearance on 2011-01-19, under 510(k) number K102195.

Who is the listed applicant for SP-FIX SPINOUS PROCESS FIXATION PLATE?

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 SP-FIX SPINOUS PROCESS FIXATION PLATE?

The FDA product code for SP-FIX SPINOUS PROCESS FIXATION PLATE 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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