FDA.reportPublic FDA data

"""LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System"""

Primary DI
08809986467676
Brand
"""LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System"""
Company
L&K BIOMED CO. ,LTD.
Model
1374-9570
Device description
SAI Screw Smooth Shank D9.5 X 70mm
Published
2025-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
KWQAppliance, Fixation, Spinal Intervertebral Body
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200790000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200790000LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.2020-10-28NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809986467676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809986467676088099864676768809986467676

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
631159324
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809986491008BluEX Cervical Expandable Cage System1417-1000S2026-06-04
08809986491015BluEX Cervical Expandable Cage System1417-1100S2026-06-04
08809986491022BluEX Cervical Expandable Cage System1417-1200S2026-06-04
08809986491039BluEX Cervical Expandable Cage System1417-1300S2026-06-04
08809986491046BluEX Cervical Expandable Cage System1417-0407S2026-06-04
08809986491053BluEX Cervical Expandable Cage System1417-0507S2026-06-04
08809986491060BluEX Cervical Expandable Cage System1417-0607S2026-06-04
08809986491077BluEX Cervical Expandable Cage System1417-0707S2026-06-04
08809986491084BluEX Cervical Expandable Cage System1417-0807S2026-06-04
08809986491091BluEX Cervical Expandable Cage System1417-0907S2026-06-04
08809986491107BluEX Cervical Expandable Cage System1417-1007S2026-06-04
08809986491114BluEX Cervical Expandable Cage System1417-1107S2026-06-04
08809986491121BluEX Cervical Expandable Cage System1417-1207S2026-06-04
08809986491138BluEX Cervical Expandable Cage System1417-1307S2026-06-04
08809986491145CastleLoc-P Anterior Cervical Plate System6911-17152026-06-04
08809986491152CastleLoc-P Anterior Cervical Plate System6911-17172026-06-04
08809986491169CastleLoc-P Anterior Cervical Plate System6911-17192026-06-04
08809986491176CastleLoc-P Anterior Cervical Plate System6911-17212026-06-04
08809986491183CastleLoc-P Anterior Cervical Plate System6911-17232026-06-04
08809986491190CastleLoc-P Anterior Cervical Plate System6911-17252026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157082031ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082048ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082055ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082062ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082079ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082086ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082093ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082109ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082116ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082123ZAVATION SCREWZavation LLCKWP2026-06-05
00810017913664Saber-C Body (PT), 12x15x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.KWQ2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.KWQ2026-06-05
00840283403897VySpan™VY SPINE LLCKWP2026-06-05
00840283403927VySpan™VY SPINE LLCKWP2026-06-05
00840283407949VyPlate™VY SPINE LLCKWQ2026-06-05
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05