FDA.report

CastleLoc-S Posterior Cervical Fixation System

Primary DI
08800061394665
Brand
CastleLoc-S Posterior Cervical Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
6202-4525
Catalog number
6202-4525
Device description
Cervical Reduction Screw D4.5, D3.5, L25
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NKGPosterior Cervical Screw System

Product Code Classifications

CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions

SubmissionSupplement
K231840000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800061394665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800061394665088000613946658800061394665

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-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. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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