FDA.reportPublic FDA data

CastleLoc-S Posterior Cervical Fixation System/LnK Posterior Cervical Fixation S

Primary DI
08806344321069
Brand
CastleLoc-S Posterior Cervical Fixation System/LnK Posterior Cervical Fixation S
Company
L&K BIOMED CO. ,LTD.
Model
6119-4050
Catalog number
6119-4050
Device description
Cervical Parially Reduction Screw Ø4.0, 50mm
Published
2016-11-16
Public version status
Update
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
NKGOrthosis, Cervical Pedicle Screw Spinal Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806344321069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806344321069088063443210698806344321069

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used 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 (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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
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
07290117359549CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-07-13
07290117359563CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-07-13
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-28
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-06-27
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-27
10889981441555VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationKWP2026-06-24
00193982572983CREOGLOBUS MEDICAL, INC.KWP2026-06-10
04052536163403neon3Ulrich GmbH & Co. KGNKG2026-06-09
04052536163403neon3Ulrich GmbH & Co. KGKWP2026-06-09
04052536163410neon3Ulrich GmbH & Co. KGKWP2026-06-09
00887517656582ReLineNuvasive, Inc.KWP2026-04-15
00841732151024PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151031PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151048PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151055PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151062PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151079PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151086PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151093PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732149847TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-15
00841732149854TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-15
00841732150621TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-15
00841732163546PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732163553PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732163560PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732163577PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14