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PathLoc-L MIS Spinal System

by L&K Biomed Co., Ltd. 2 variants

510(k) K161766

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK161766 Date22 Aug 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NKB
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PathLoc-L MIS Spinal System is a minimally invasive spinal fixation device designed for posterior rod and screw fixation. It provides immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion, addressing acute and chronic instabilities or deformities in the thoracic, lumbar, and sacral spine regions.

This system is used in surgical settings for spinal stabilization and is intended for single-use. It employs a transmuscular approach and subfascial rod insertion to minimize soft tissue trauma. The device holds an FDA 510(k) clearance (K161766) under the Traditional pathway, classified under the Orthopedic advisory committee with product code NKB.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of spinal conditions is the PathLoc-L MIS Spinal System designed to address in patients?

    The PathLoc-L MIS Spinal System is specifically designed for skeletally mature patients to provide immobilization and stabilization of spinal segments in cases of acute or chronic instabilities or deformities. It is intended for use in the thoracic, lumbar, and sacral regions of the spine as an adjunct to fusion, helping to support surgical outcomes where spinal alignment and fixation are critical.

  • How is the PathLoc-L MIS Spinal System different from traditional spinal fixation methods in terms of surgical approach?

    Unlike traditional open spinal surgery, the PathLoc-L MIS Spinal System uses a minimally invasive approach, employing a transmuscular technique and subfascial rod insertion. This design reduces soft tissue trauma, which can lead to less postoperative pain, shorter recovery times, and improved patient outcomes compared to conventional methods.

  • Is the PathLoc-L MIS Spinal System reusable, or is it intended for single-use only?

    The PathLoc-L MIS Spinal System is explicitly intended for single-use only, as stated in the manufacturer’s description. This ensures patient safety and reduces the risk of cross-contamination or device degradation from repeated sterilization processes.

  • What regulatory pathway was followed for FDA clearance of the PathLoc-L MIS Spinal System, and what does that mean for its use?

    The PathLoc-L MIS Spinal System received FDA clearance through the Traditional 510(k) pathway, classified under the Orthopedic advisory committee with product code NKB. This means the device was determined to be substantially equivalent to a legally marketed predicate device, confirming its safety and effectiveness for the intended use in spinal stabilization procedures.