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FDA 510(k)

SIJF CANNULATED SCREW SYSTEM

K-Number: K051296 · 2005-08-26

ApplicantDepuy Spine, Inc.
Decision Date2005-08-26
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIJF CANNULATED SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine, Inc.. It received FDA 510(k) clearance on 2005-08-26 under 510(k) number K051296. 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 SIJF CANNULATED SCREW SYSTEM?

SIJF CANNULATED SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-26. The listed applicant is Depuy Spine, Inc.. The 510(k) number is K051296.

When did SIJF CANNULATED SCREW SYSTEM receive FDA 510(k) clearance?

SIJF CANNULATED SCREW SYSTEM received FDA 510(k) clearance on 2005-08-26, under 510(k) number K051296.

Who is the listed applicant for SIJF CANNULATED SCREW SYSTEM?

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

What is the FDA product code for SIJF CANNULATED SCREW SYSTEM?

The FDA product code for SIJF CANNULATED SCREW SYSTEM is OUR.

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Other records listing Depuy Spine, Inc. as applicant

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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

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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