Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PathLoc-SI Joint Fusion System

K-Number: K153656 · 2016-11-14

ApplicantL&K BIOMED Co., Ltd.
Decision Date2016-11-14
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PathLoc-SI Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2016-11-14 under 510(k) number K153656. 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 PathLoc-SI Joint Fusion System?

PathLoc-SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2016-11-14. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K153656.

When did PathLoc-SI Joint Fusion System receive FDA 510(k) clearance?

PathLoc-SI Joint Fusion System received FDA 510(k) clearance on 2016-11-14, under 510(k) number K153656.

Who is the listed applicant for PathLoc-SI Joint Fusion System?

The FDA 510(k) record lists L&K BIOMED Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PathLoc-SI Joint Fusion System?

The FDA product code for PathLoc-SI Joint Fusion System is OUR.

Other records listing L&K BIOMED Co., Ltd. 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.

K260840BluEX Cervical Expandable Cage SystemK261112CastleLoc-P Anterior Cervical Plate SystemK261130AccelFix Spinal Fixation SystemK260448CastleLoc Pectus Bar SystemK251940PathLoc Lumbar Plate SystemK251741PathLoc Lumbar Interbody Fusion Cage System

View all 38 devices →

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.

K260477CATAMARAN™ 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, LLCK252322SIros-X SystemGenesys Spine

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.

↑