PathLoc-L MIS Spinal System, LnK MIS Spinal System 2905-5560

GUDID 08806344337787

MIS Screw – Close Type(Non Self-tapping) 5.5mmx60mm

L&K BIOMED CO. ,LTD.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08806344337787
• NIH Device Record Key: 7f7fbf13-e7e0-4c07-8b79-d629ad9d6daf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PathLoc-L MIS Spinal System, LnK MIS Spinal System
• Version Model Number: 2905-5560
• Catalog Number: 2905-5560
• Company DUNS: 631159324
• Company Name: L&K BIOMED CO. ,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806344337787 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161766

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08806344337787]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-09
• Device Publish Date: 2017-03-06

On-Brand Devices [PathLoc-L MIS Spinal System, LnK MIS Spinal System]

• 08806344341142: MIS Screw – Open Type(Non Self-tapping) 5.5mmx60mm
• 08806344340930: MIS Screw – Open Type(Non Self-tapping) 5.5mmx60mm
• 08806344340725: MIS Screw – Open Type(Non Self-tapping) 5.5mmx60mm
• 08806344340510: MIS Screw – Open Type(Non Self-tapping) 5.5mmx60mm
• 08806344340305: MIS Screw – Open Type(Non Self-tapping) 5.5mmx60mm
• 08806344340091: MIS Screw – Open Type(Non Self-tapping) 5.5mmx60mm
• 08806344339880: MIS Screw – Open Type(Non Self-tapping) 5.5mmx60mm
• 08806344339675: MIS Screw – Open Type(Non Self-tapping) 5.5mmx60mm
• 08806344339460: MIS Screw – Open Type(Non Self-tapping) 5.5mmx60mm
• 08806344339255: MIS Screw – Close Type(Non Self-tapping) 5.5mmx60mm
• 08806344339040: MIS Screw – Close Type(Non Self-tapping) 5.5mmx60mm
• 08806344338838: MIS Screw – Close Type(Non Self-tapping) 5.5mmx60mm
• 08806344338623: MIS Screw – Close Type(Non Self-tapping) 5.5mmx60mm
• 08806344338418: MIS Screw – Close Type(Non Self-tapping) 5.5mmx60mm
• 08806344338203: MIS Screw – Close Type(Non Self-tapping) 5.5mmx60mm
• 08806344337992: MIS Screw – Close Type(Non Self-tapping) 5.5mmx60mm
• 08806344337787: MIS Screw – Close Type(Non Self-tapping) 5.5mmx60mm
• 08806344337572: MIS Screw – Close Type(Non Self-tapping) 5.5mmx60mm
• 08806344320154: MIS Screw – Open Type(Self-tapping) 5.5mmx60mm
• 08806344319943: MIS Screw – Open Type(Self-tapping) 5.5mmx60mm
• 08806344319738: MIS Screw – Open Type(Self-tapping) 5.5mmx60mm
• 08806344319523: MIS Screw – Open Type(Self-tapping) 5.5mmx60mm
• 08806344319318: MIS Screw – Open Type(Self-tapping) 5.5mmx60mm
• 08806344319103: MIS Screw – Open Type(Self-tapping) 5.5mmx60mm
• 08806344318892: MIS Screw – Open Type(Self-tapping) 5.5mmx60mm
• 08806344318687: MIS Screw – Open Type(Self-tapping) 5.5mmx60mm
• 08806344318472: MIS Screw – Open Type(Self-tapping) 5.5mmx60mm
• 08806344318267: MIS Screw – Close Type(Self-tapping) 5.5mmx60mm
• 08806344318052: MIS Screw – Close Type(Self-tapping) 5.5mmx60mm
• 08806344317840: MIS Screw – Close Type(Self-tapping) 5.5mmx60mm
• 08806344317635: MIS Screw – Close Type(Self-tapping) 5.5mmx60mm
• 08806344317420: MIS Screw – Close Type(Self-tapping) 5.5mmx60mm
• 08806344317215: MIS Screw – Close Type(Self-tapping) 5.5mmx60mm
• 08806344317000: MIS Screw – Close Type(Self-tapping) 5.5mmx60mm
• 08806344316799: MIS Screw – Close Type(Self-tapping) 5.5mmx60mm
• 08806344316584: MIS Screw – Close Type(Self-tapping) 5.5mmx60mm
• 08806344316379: MIS Screw – Open Type(Self-tapping, Double Thread) 5.5mmx60mm
• 08806344316164: MIS Screw – Open Type(Self-tapping, Double Thread) 5.5mmx60mm
• 08806344315952: MIS Screw – Open Type(Self-tapping, Double Thread) 5.5mmx60mm
• 08806344315747: MIS Screw – Open Type(Self-tapping, Double Thread) 5.5mmx60mm
• 08806344315327: MIS Screw – Open Type(Self-tapping, Double Thread) 5.5mmx60mm
• 08806344315112: MIS Screw – Open Type(Self-tapping, Double Thread) 5.5mmx60mm
• 08806344314900: MIS Screw – Open Type(Self-tapping, Double Thread) 5.5mmx60mm
• 08806344314696: MIS Screw – Open Type(Self-tapping, Double Thread) 5.5mmx60mm
• 08806344314481: MIS Screw – Close Type(Self-tapping, Double Thread) 5.5mmx60mm
• 08806344314276: MIS Screw – Close Type(Self-tapping, Double Thread) 5.5mmx60mm
• 08806344314061: MIS Screw – Close Type(Self-tapping, Double Thread) 5.5mmx60mm
• 08806344313859: MIS Screw – Close Type(Self-tapping, Double Thread) 5.5mmx60mm
• 08806344313644: MIS Screw – Close Type(Self-tapping, Double Thread) 5.5mmx60mm
• 08806344313439: MIS Screw – Close Type(Self-tapping, Double Thread) 5.5mmx60mm