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FDA 510(k)

OpenLoc-L Spinal Fixation System

K-Number: K183168 · 2018-12-11

ApplicantL&K BIOMED Co., Ltd.
Decision Date2018-12-11
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OpenLoc-L Spinal Fixation 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 2018-12-11 under 510(k) number K183168. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OpenLoc-L Spinal Fixation System?

OpenLoc-L Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2018-12-11. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K183168.

When did OpenLoc-L Spinal Fixation System receive FDA 510(k) clearance?

OpenLoc-L Spinal Fixation System received FDA 510(k) clearance on 2018-12-11, under 510(k) number K183168.

Who is the listed applicant for OpenLoc-L Spinal Fixation 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 OpenLoc-L Spinal Fixation System?

The FDA product code for OpenLoc-L Spinal Fixation System is NKB.

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.

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Related Devices (Code: NKB)

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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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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