FDA.report

LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System

Primary DI
08800061699418
Brand
LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
1165-50400S
Catalog number
1165-50400S
Device description
S rod
Published
2023-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications

CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions

SubmissionSupplement
K231636000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K231636000LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.L&K BIOMED Co., Ltd.2023-06-27NKB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800061699418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800061699418088000616994188800061699418

GMDN Terms

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

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

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08809986488749CastleLoc Pectus Bar System Instrument SetPB01-08022026-03-09
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08809986488862CastleLoc Pectus Bar System Instrument SetPB02-0001S2026-03-09
08809986488879CastleLoc Pectus Bar System Instrument SetPB02-0001M2026-03-09
08809986488886CastleLoc Pectus Bar System Instrument SetPB02-0001L2026-03-09
08809986488893CastleLoc Pectus Bar System Instrument SetPB02-0002S2026-03-09
08809986488909CastleLoc Pectus Bar System Instrument SetPB02-0002M2026-03-09

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