FDA.reportPublic FDA data

CastleLoc-P Anterior Cervical Plate System

Primary DI
08809986492784
Brand
CastleLoc-P Anterior Cervical Plate System
Company
L&K BIOMED CO. ,LTD.
Model
6610-4019S
Device description
Variable Cervical Plate Screw (Self Drilling, Star, Conical/ Dual Thread Dia. 4.0, 19mm)
Published
2026-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K261112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261112000CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.2026-05-06KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809986492784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809986492784088099864927848809986492784

Regulatory Flags#

DUNS number
631159324
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809986489814LnK Spinal Instrument SystemCM138-XTP01-185506062026-11-05
08809986489821LnK Spinal Instrument SystemCM138-XTP01-185508062026-11-05
08809986489838LnK Spinal Instrument SystemCM138-XTP01-185510062026-11-05
08809986489845LnK Spinal Instrument SystemXTP01-18550606C012026-11-05
08809986489852LnK Spinal Instrument SystemXTP01-18550806C012026-11-05
08809986489869LnK Spinal Instrument SystemXTP01-18551006C012026-11-05
08809986489876LnK Spinal Instrument SystemLC04-1207SC022026-11-05
08809986489883LnK Spinal Instrument SystemLC04-1207SC032026-11-05
08809986489890LnK Spinal Instrument SystemLC04-1207SC042026-11-05
08809986489906LnK Spinal Instrument SystemLP01-0603C012026-11-05
08809986487339CastleLoc Pectus Bar SystemBC05-014092025-10-29
08809986487360CastleLoc Pectus Bar SystemBC05-01752025-10-24
08809986485137CastleLoc Pectus Bar SystemOB30-91852026-10-29
08809986485144CastleLoc Pectus Bar SystemOB30-91902026-10-29
08809986485151CastleLoc Pectus Bar SystemOB30-91952026-10-29
08809986485168CastleLoc Pectus Bar SystemOB30-92002026-10-29
08809986485274CastleLoc Pectus Bar SystemWB28-61002026-10-29
08809986485281CastleLoc Pectus Bar SystemWB28-61052026-10-29
08809986485298CastleLoc Pectus Bar SystemWB28-61102026-10-29
08809986485304CastleLoc Pectus Bar SystemWB28-61152026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169371TAURUS LX Pedicle Screw SystemCTL Medical CorporationKWQ2026-11-04
08800322699775AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800322699782AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800322699799AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704032AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704049AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704056AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719654AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719661AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719678AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719685AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719692AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799939AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799946AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799953AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809969AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809976AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809983AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809990AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819852AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819869AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819876AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819883AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819890AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819906AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819913AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819920AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819937AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819944AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
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