FDA.reportPublic FDA data

CastleLoc-P Anterior Cervical Plate System

Primary DI
08809986492753
Brand
CastleLoc-P Anterior Cervical Plate System
Company
L&K BIOMED CO. ,LTD.
Model
6610-4016S
Device description
Variable Cervical Plate Screw (Self Drilling, Star, Conical/ Dual Thread Dia. 4.0, 16mm)
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
08809986492753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809986492753088099864927538809986492753

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; 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). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

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
08809986482440CastleLoc Pectus Bar SystemPF12-20222026-08-25
08809986482457CastleLoc Pectus Bar SystemPF12-23122026-08-25
08809986482464CastleLoc Pectus Bar SystemPF12-23152026-08-25
08809986482471CastleLoc Pectus Bar SystemPF12-23182026-08-25
08809986482488CastleLoc Pectus Bar SystemPF12-23222026-08-25
08809986482495CastleLoc Pectus Bar SystemPF12-25182026-08-25
08809986481894CastleLoc Pectus Bar SystemPB25-E1602026-08-21
08809986481900CastleLoc Pectus Bar SystemPB25-E1652026-08-21
08809986481917CastleLoc Pectus Bar SystemPB25-E1702026-08-21
08809986481924CastleLoc Pectus Bar SystemPB10-00032026-08-21
08809986481931CastleLoc Pectus Bar SystemPB10-00072026-08-21
08809986481948CastleLoc Pectus Bar SystemPB10-00082026-08-21
08809986481955CastleLoc Pectus Bar SystemPB10-00092026-08-21
08809986481962CastleLoc Pectus Bar SystemPB10-00102026-08-21
08809986481979CastleLoc Pectus Bar SystemPB10-00112026-08-21
08809986481986CastleLoc Pectus Bar SystemPB10-00122026-08-21
08809986481993CastleLoc Pectus Bar SystemPB10-00132026-08-21
08809986482006CastleLoc Pectus Bar SystemPB10-00142026-08-21
08809986482013CastleLoc Pectus Bar SystemPB10-00152026-08-21
08809986482020CastleLoc Pectus Bar SystemPB10-00162026-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857037953EVEREST® Spinal SystemVB Spine LLCKWQ2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCKWQ2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857046733MESA® Small Stature Spinal SystemVB Spine LLCKWQ2016-09-02
10888857008724EVEREST® Spinal SystemVB Spine LLCKWQ2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001763DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001787DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001824DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001848DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001923DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001947DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001978DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001992DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002036DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002050DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002074DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002098DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24