FDA.report

CastleLoc-S Posterior Cervical Fixation System/LnK Posterior Cervical Fixation S

Primary DI
08806344321793
Brand
CastleLoc-S Posterior Cervical Fixation System/LnK Posterior Cervical Fixation S
Company
L&K BIOMED CO. ,LTD.
Model
6141-2002
Catalog number
6141-2002
Device description
Cross Link Bar Type 34-42
Published
2016-11-16
Public version status
Update
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
NKGOrthosis, Cervical Pedicle Screw Spinal Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08806344321793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08806344321793088063443217938806344321793

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at each end, into which screw heads/rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a transverse connecting element to be attached to corresponding bilateral screw heads or rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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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