FDA.reportPublic FDA data

CastleLoc-S Posterior Cervical Fixation System

Primary DI
08800061395051
Brand
CastleLoc-S Posterior Cervical Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
6201-5545S
Catalog number
6201-5545S
Device description
Cervical Ploy Axial Screw D5.5, D3.5, L45
Published
2023-08-03
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
08800061395051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800061395051088000613950518800061395051

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
08809986484031CastleLoc Pectus Bar SystemOB28-11002025-10-29
08809986484055CastleLoc Pectus Bar SystemOB28-11102025-10-29
08809986484062CastleLoc Pectus Bar SystemOB28-11152025-10-29
08809986484079CastleLoc Pectus Bar SystemOB28-11202025-10-29
08809986484086CastleLoc Pectus Bar SystemOB28-11252025-10-29
08809986484093CastleLoc Pectus Bar SystemOB28-11302025-10-29
08809986484109CastleLoc Pectus Bar SystemOB28-11352025-10-29
08809986484116CastleLoc Pectus Bar SystemOB28-11402025-10-29
08809986484130CastleLoc Pectus Bar SystemOB28-11502025-10-29
08809986489807LnK Spinal Instrument SystemCC10-00112026-10-19
08809986482815CastleLoc Pectus Bar SystemOB28-01102026-04-17
08809986482822CastleLoc Pectus Bar SystemOB28-01152026-04-17
08809986482839CastleLoc Pectus Bar SystemOB28-01202026-04-17
08809986482846CastleLoc Pectus Bar SystemOB28-01252026-04-17
08809986482853CastleLoc Pectus Bar SystemOB28-01302026-04-17
08809986482860CastleLoc Pectus Bar SystemOB28-01352026-04-17
08809986482778CastleLoc Pectus Bar SystemOB28-00902025-07-21
08809986482785CastleLoc Pectus Bar SystemOB28-00952025-07-21
08809986482716CastleLoc Pectus Bar SystemOB28-00602025-07-18
08809986482723CastleLoc Pectus Bar SystemOB28-00652025-07-18

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Primary DI, Brand, Company table
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