FDA.reportPublic FDA data

CastleLoc-P Anterior Cervical Plate System

Primary DI
08800061394351
Brand
CastleLoc-P Anterior Cervical Plate System
Company
L&K BIOMED CO. ,LTD.
Model
6713-1745S
Catalog number
6713-1745S
Device description
Cervical Plate Contour Type (3 Level 45mm)
Published
2023-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231839000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231839000CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.2023-07-19KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800061394351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800061394351088000613943518800061394351

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and 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 typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
631159324
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809986483843CastleLoc Pectus Bar SystemWB30-51602026-10-28
08809986483850CastleLoc Pectus Bar SystemWB30-51652026-10-28
08809986483867CastleLoc Pectus Bar SystemWB30-51702026-10-28
08809986483874CastleLoc Pectus Bar SystemWB30-51752026-10-28
08809986483881CastleLoc Pectus Bar SystemWB30-51802026-10-28
08809986483898CastleLoc Pectus Bar SystemWB30-51852026-10-28
08809986483904CastleLoc Pectus Bar SystemWB30-51902026-10-28
08809986483911CastleLoc Pectus Bar SystemWB30-51952026-10-28
08809986483928CastleLoc Pectus Bar SystemWB30-52002026-10-28
08809986484048CastleLoc Pectus Bar SystemOB28-11052026-10-28
08809986484123CastleLoc Pectus Bar SystemOB28-11452026-10-28
08809986484147CastleLoc Pectus Bar SystemOB28-11552026-10-28
08809986484154CastleLoc Pectus Bar SystemOB28-11602026-10-28
08809986484161CastleLoc Pectus Bar SystemOB28-11652026-10-28
08809986484178CastleLoc Pectus Bar SystemOB28-11702026-10-28
08809986484185CastleLoc Pectus Bar SystemOB28-11752026-10-28
08809986484192CastleLoc Pectus Bar SystemOB28-11802026-10-28
08809986484208CastleLoc Pectus Bar SystemOB28-11852026-10-28
08809986484215CastleLoc Pectus Bar SystemOB28-11902026-10-28
08809986484222CastleLoc Pectus Bar SystemOB28-11952026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810017913770Saber-C Body (PT), 14x15x6 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913787Saber-C Body (PT), 14x15x7 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913794Saber-C Body (PT), 14x15x8 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913800Saber-C Body (PT), 14x15x9 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913817Saber-C Body (PT), 14x15x10 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913824Saber-C Body (PT), 14x15x5 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913930Saber-C Body (PT), 14x17x10 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913947Saber-C Body (PT), 14x17x5 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913954Saber-C Body (PT), 14x17x6 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913961Saber-C Body (PT), 14x17x7 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913978Saber-C Body (PT), 14x17x8 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913985Saber-C Body (PT), 14x17x9 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913992Saber-C Body (PT), 14x17x10 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914005Saber-C Body (PT), 15x18x5 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914012Saber-C Body (PT), 15x18x6 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914029Saber-C Body (PT), 15x18x7 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914036Saber-C Body (PT), 15x18x8 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914043Saber-C Body (PT), 15x18x9 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914050Saber-C Body (PT), 15x18x10 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914425Saber-C Body (PT), 14x15x6 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914432Saber-C Body (PT), 14x15x7 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914449Saber-C Body (PT), 14x15x8 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914456Saber-C Body (PT), 14x15x9 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914463Saber-C Body (PT), 14x15x10 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914654Saber-C Body (PT), 15x18x5 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
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