FDA.reportPublic FDA data

AccelFix Spinal Fixation System

Primary DI
08800061316193
Brand
AccelFix Spinal Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
2302-60130
Catalog number
2302-60130
Device description
Percutaneous Poly Screw Open Type Ø6.0 , 130mm
Published
2020-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
KWQAppliance, Fixation, Spinal Intervertebral Body
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182544000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182544000AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.2019-05-28NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800061316193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800061316193088000613161938800061316193

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
631159324
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809986490001CastleLoc Pectus Bar SystemPB28-01752026-05-27
08809986490018CastleLoc Pectus Bar SystemPB28-01802026-05-27
08809986490025CastleLoc Pectus Bar SystemPB28-01852026-05-27
08809986490032CastleLoc Pectus Bar SystemPB28-01902026-05-27
08809986490049CastleLoc Pectus Bar SystemPB28-01952026-05-27
08809986490056CastleLoc Pectus Bar SystemPB28-02002026-05-27
08809986490063CastleLoc Pectus Bar SystemPB30-01752026-05-27
08809986490087CastleLoc Pectus Bar SystemPB30-01852026-05-27
08809986490094CastleLoc Pectus Bar SystemPB30-01902026-05-27
08809986490100CastleLoc Pectus Bar SystemPB30-01952026-05-27
08809986490117CastleLoc Pectus Bar SystemPB30-02002026-05-27
08809986490124CastleLoc Pectus Bar SystemPB28-11752026-05-27
08809986490131CastleLoc Pectus Bar SystemPB28-11802026-05-27
08809986490148CastleLoc Pectus Bar SystemPB28-11852026-05-27
08809986490155CastleLoc Pectus Bar SystemPB28-11902026-05-27
08809986490162CastleLoc Pectus Bar SystemPB28-11952026-05-27
08809986490179CastleLoc Pectus Bar SystemPB28-12002026-05-27
08809986490186CastleLoc Pectus Bar SystemPB30-11752026-05-27
08809986490193CastleLoc Pectus Bar SystemPB30-11802026-05-27
08809986490209CastleLoc Pectus Bar SystemPB30-11852026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157058982ZAVATION INSTRUMENT TRAYZavation LLCNKB2026-06-02
00197157058999ZAVATION INSTRUMENT TRAYZavation LLCNKB2026-06-02
00197157059002ZAVATION INSTRUMENT TRAYZavation LLCNKB2026-06-02
00197157059019ZAVATION INSTRUMENT TRAYZavation LLCNKB2026-06-02
00197157059026ZAVATION INSTRUMENT TRAYZavation LLCNKB2026-06-02
00197157059033ZAVATION INSTRUMENT TRAYZavation LLCNKB2026-06-02
00197157059040ZAVATION INSTRUMENT TRAYZavation LLCNKB2026-06-02
00197157059057ZAVATION CADDYZavation LLCNKB2026-06-02
00197157059064ZAVATION CADDYZavation LLCNKB2026-06-02
00197157059071ZAVATION RODZavation LLCNKB2026-06-02
00197157059088ZAVATION RODZavation LLCNKB2026-06-02
00197157059095ZAVATION RODZavation LLCNKB2026-06-02
00197157059101ZAVATION RODZavation LLCNKB2026-06-02
00197157059118ZAVATION RODZavation LLCNKB2026-06-02
00197157059125ZAVATION RODZavation LLCNKB2026-06-02
00197157059132ZAVATION RODZavation LLCNKB2026-06-02
00197157059149ZAVATION RODZavation LLCNKB2026-06-02
00197157059156ZAVATION RODZavation LLCNKB2026-06-02
00197157059163ZAVATION RODZavation LLCNKB2026-06-02
00197157059170ZAVATION RODZavation LLCNKB2026-06-02
00197157059187ZAVATION RODZavation LLCNKB2026-06-02
00197157059194ZAVATION RODZavation LLCNKB2026-06-02
00197157059200ZAVATION RODZavation LLCNKB2026-06-02
00197157059217ZAVATION RODZavation LLCNKB2026-06-02
00197157059224ZAVATION RODZavation LLCNKB2026-06-02
00197157059231ZAVATION RODZavation LLCNKB2026-06-02
00197157059248ZAVATION RODZavation LLCNKB2026-06-02
00197157059255ZAVATION RODZavation LLCNKB2026-06-02
00197157059262ZAVATION RODZavation LLCNKB2026-06-02
00197157059279ZAVATION RODZavation LLCNKB2026-06-02