FDA.reportPublic FDA data

LnK Spinal Instrument System

Primary DI
08800108689341
Brand
LnK Spinal Instrument System
Company
L&K BIOMED CO. ,LTD.
Model
LS05-0621
Catalog number
LS05-0621
Device description
FINAL SET SCREW DRIVER
Published
2023-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800108689341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800108689341088001086893418800108689341

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
631159324
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809986492791CastleLoc-P Anterior Cervical Plate System6610-4020S2026-06-09
08809986492807CastleLoc-P Anterior Cervical Plate System6610-4021S2026-06-09
08809986492814CastleLoc-P Anterior Cervical Plate System6610-4022S2026-06-09
08809986479938CastleLoc Pectus Bar SystemPB28-31602026-06-08
08809986479945CastleLoc Pectus Bar SystemPB28-21602026-06-08
08809986491404CastleLoc-P Anterior Cervical Plate System6913-17602026-06-08
08809986491411CastleLoc-P Anterior Cervical Plate System6913-17632026-06-08
08809986491428CastleLoc-P Anterior Cervical Plate System6913-17662026-06-08
08809986491435CastleLoc-P Anterior Cervical Plate System6913-17692026-06-08
08809986491442CastleLoc-P Anterior Cervical Plate System6913-17722026-06-08
08809986491459CastleLoc-P Anterior Cervical Plate System6914-17652026-06-08
08809986491466CastleLoc-P Anterior Cervical Plate System6914-17692026-06-08
08809986491473CastleLoc-P Anterior Cervical Plate System6914-17732026-06-08
08809986491480CastleLoc-P Anterior Cervical Plate System6914-17772026-06-08
08809986491497CastleLoc-P Anterior Cervical Plate System6914-17812026-06-08
08809986491503CastleLoc-P Anterior Cervical Plate System6914-17852026-06-08
08809986491510CastleLoc-P Anterior Cervical Plate System6914-17892026-06-08
08809986491527CastleLoc-P Anterior Cervical Plate System6914-17932026-06-08
08809986491534CastleLoc-P Anterior Cervical Plate System6914-17972026-06-08
08809986491541CastleLoc-P Anterior Cervical Plate System6609-35122026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17
00889929072219NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072226NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072233NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072264NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072271NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072288NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072295NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072301NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072318NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072325NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072332NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072349Matrixx SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072356NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072363NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072394NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072448Matrixx SystemNEXXT SPINE, LLCLXH2026-07-17