FDA.reportPublic FDA data

CastleLoc-S Posterior Cervical Fixation System

Primary DI
08800061395259
Brand
CastleLoc-S Posterior Cervical Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
6202-5540S
Catalog number
6202-5540S
Device description
Cervical Reduction Screw D5.5, D3.5, L40
Published
2023-08-07
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
KWPAppliance, Fixation, Spinal Interlaminal
NKGPosterior Cervical Screw System

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231840000CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.2023-07-20NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800061395259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800061395259088000613952598800061395259

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
631159324
Device count
1
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
08809986493309LnK Spinal Instrument SystemTA24-08092026-09-18
08809986493316LnK Spinal Instrument SystemTA24-08122026-09-18
08809986493323LnK Spinal Instrument SystemTA24-08152026-09-18
08809986493330LnK Spinal Instrument SystemTA24-12092026-09-18
08809986493347LnK Spinal Instrument SystemTA24-12122026-09-18
08809986493354LnK Spinal Instrument SystemTA24-12152026-09-18
08809986493361LnK Spinal Instrument SystemTA24-15062026-09-18
08809986493378LnK Spinal Instrument SystemTA24-15092026-09-18
08809986493385LnK Spinal Instrument SystemTA24-15122026-09-18
08809986493392LnK Spinal Instrument SystemTA24-15152026-09-18
08809986493408LnK Spinal Instrument SystemTA24-20062026-09-18
08809986493415LnK Spinal Instrument SystemTA24-20092026-09-18
08809986493422LnK Spinal Instrument SystemTA24-20122026-09-18
08809986493439LnK Spinal Instrument SystemTA24-20152026-09-18
08809986493446LnK Spinal Instrument SystemTA24-25062026-09-18
08809986493453LnK Spinal Instrument SystemTA24-25092026-09-18
08809986493460LnK Spinal Instrument SystemTA24-25122026-09-18
08809986493477LnK Spinal Instrument SystemTA24-25152026-09-18
08809986493484LnK Spinal Instrument SystemTA24-30062026-09-18
08809986493491LnK Spinal Instrument SystemTA24-30092026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000891428CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-09-20
00763000891480CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-09-20
00763000992538INFINITY OCT SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-09-20
00763000992545INFINITY OCT SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-09-20
00763000992569INFINITY OCT SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-09-20
10888857037953EVEREST® Spinal SystemVB Spine LLCKWP2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCKWP2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857046733MESA® Small Stature Spinal SystemVB Spine LLCKWP2016-09-02
10888857008724EVEREST® Spinal SystemVB Spine LLCKWP2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001763DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001787DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001824DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001848DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001923DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001947DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001978DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24