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FDA 510(k)

SI-LOK SACROILIAC JOINT FIXATION SYSTEM

K-Number: K112028 · 2011-12-09

ApplicantGlobus Medical, Inc.
Decision Date2011-12-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SI-LOK SACROILIAC JOINT FIXATION 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 2011-12-09 under 510(k) number K112028. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SI-LOK SACROILIAC JOINT FIXATION SYSTEM?

SI-LOK SACROILIAC JOINT FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-09. The listed applicant is Globus Medical, Inc.. The 510(k) number is K112028.

When did SI-LOK SACROILIAC JOINT FIXATION SYSTEM receive FDA 510(k) clearance?

SI-LOK SACROILIAC JOINT FIXATION SYSTEM received FDA 510(k) clearance on 2011-12-09, under 510(k) number K112028.

Who is the listed applicant for SI-LOK SACROILIAC JOINT FIXATION 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 SI-LOK SACROILIAC JOINT FIXATION SYSTEM?

The FDA product code for SI-LOK SACROILIAC JOINT FIXATION SYSTEM is HWC. This falls under the Cardiovascular category.

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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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