FDA.reportPublic FDA data

AccelFix Spinal Fixation System

Primary DI
08809986475640
Brand
AccelFix Spinal Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
1385-95100S
Device description
Poly Axial Screw (Full Thread), 9.5x100mm
Published
2025-04-14
Public version status
New
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
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
K200794000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200794000AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.2020-10-20NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809986475640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809986475640088099864756408809986475640

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
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
03700780634583Erisma®-LPCLARIANCENKB2026-05-28
04052536085491neon3Ulrich GmbH & Co. KGKWP2026-05-28
06009699900008Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900503Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900817Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900831Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900848Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900855Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900862Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900879Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900886Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900893Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900909Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900916Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900923Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900930Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900947Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900954Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900961Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900978Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900985Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900992Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901005Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901012Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901029Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901036Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901043Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901050Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901067Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901074Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28