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FDA 510(k)

SIMMETRY SACROILIAC JOINT FUSION SYSTEM

K-Number: K110512 · 2011-03-23

ApplicantZyga Technology, Inc.
Decision Date2011-03-23
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIMMETRY SACROILIAC JOINT FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zyga Technology, Inc.. It received FDA 510(k) clearance on 2011-03-23 under 510(k) number K110512. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMMETRY SACROILIAC JOINT FUSION SYSTEM?

SIMMETRY SACROILIAC JOINT FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-23. The listed applicant is Zyga Technology, Inc.. The 510(k) number is K110512.

When did SIMMETRY SACROILIAC JOINT FUSION SYSTEM receive FDA 510(k) clearance?

SIMMETRY SACROILIAC JOINT FUSION SYSTEM received FDA 510(k) clearance on 2011-03-23, under 510(k) number K110512.

Who is the listed applicant for SIMMETRY SACROILIAC JOINT FUSION SYSTEM?

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

What is the FDA product code for SIMMETRY SACROILIAC JOINT FUSION SYSTEM?

The FDA product code for SIMMETRY SACROILIAC JOINT FUSION SYSTEM is OUR.

Related Clinical Trials

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.

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Other records listing Zyga Technology, 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.

K130092SIMMETRY SACROILIAC JOINT FUSION SYSTEMK111801SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEMK102907SIMMETRY SACROILIAC JOINT FUSION SYSTEM

Related Devices (Code: OUR)

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.

K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLCK260477CATAMARAN™ SI Joint Fusion SystemTenon MedicalK253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalK251365OptumSI Implant SystemSi Solutions, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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