FDA.reportPublic FDA data

CastleLoc-S Posterior Cervical Fixation System

Primary DI
08800061395204
Brand
CastleLoc-S Posterior Cervical Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
6202-5050S
Catalog number
6202-5050S
Device description
Cervical Reduction Screw D5.0, D3.5, L50
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
08800061395204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800061395204088000613952048800061395204

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
08809986492791CastleLoc-P Anterior Cervical Plate System6610-4020S2026-06-09
08809986492807CastleLoc-P Anterior Cervical Plate System6610-4021S2026-06-09
08809986492814CastleLoc-P Anterior Cervical Plate System6610-4022S2026-06-09
08809986479938CastleLoc Pectus Bar SystemPB28-31602026-06-08
08809986479945CastleLoc Pectus Bar SystemPB28-21602026-06-08
08809986491404CastleLoc-P Anterior Cervical Plate System6913-17602026-06-08
08809986491411CastleLoc-P Anterior Cervical Plate System6913-17632026-06-08
08809986491428CastleLoc-P Anterior Cervical Plate System6913-17662026-06-08
08809986491435CastleLoc-P Anterior Cervical Plate System6913-17692026-06-08
08809986491442CastleLoc-P Anterior Cervical Plate System6913-17722026-06-08
08809986491459CastleLoc-P Anterior Cervical Plate System6914-17652026-06-08
08809986491466CastleLoc-P Anterior Cervical Plate System6914-17692026-06-08
08809986491473CastleLoc-P Anterior Cervical Plate System6914-17732026-06-08
08809986491480CastleLoc-P Anterior Cervical Plate System6914-17772026-06-08
08809986491497CastleLoc-P Anterior Cervical Plate System6914-17812026-06-08
08809986491503CastleLoc-P Anterior Cervical Plate System6914-17852026-06-08
08809986491510CastleLoc-P Anterior Cervical Plate System6914-17892026-06-08
08809986491527CastleLoc-P Anterior Cervical Plate System6914-17932026-06-08
08809986491534CastleLoc-P Anterior Cervical Plate System6914-17972026-06-08
08809986491541CastleLoc-P Anterior Cervical Plate System6609-35122026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-30
00840606193382Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193399Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193405Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193412Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193429Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193436Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193443Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193450Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194044Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194051Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194068Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194075Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194082Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194099Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194105Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194112Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194129Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194136Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194143Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194150Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194167Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194174Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194181Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194198Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194204Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194211Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194228Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194235Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30