FDA.reportPublic FDA data

AccelFix Spinal Fixation System

Primary DI
08800061316117
Brand
AccelFix Spinal Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
2302-6090
Catalog number
2302-6090
Device description
Percutaneous Poly Screw Open Type Ø6.0 , 90mm
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
08800061316117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800061316117088000613161178800061316117

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
08809986482440CastleLoc Pectus Bar SystemPF12-20222026-08-25
08809986482457CastleLoc Pectus Bar SystemPF12-23122026-08-25
08809986482464CastleLoc Pectus Bar SystemPF12-23152026-08-25
08809986482471CastleLoc Pectus Bar SystemPF12-23182026-08-25
08809986482488CastleLoc Pectus Bar SystemPF12-23222026-08-25
08809986482495CastleLoc Pectus Bar SystemPF12-25182026-08-25
08809986481894CastleLoc Pectus Bar SystemPB25-E1602026-08-21
08809986481900CastleLoc Pectus Bar SystemPB25-E1652026-08-21
08809986481917CastleLoc Pectus Bar SystemPB25-E1702026-08-21
08809986481924CastleLoc Pectus Bar SystemPB10-00032026-08-21
08809986481931CastleLoc Pectus Bar SystemPB10-00072026-08-21
08809986481948CastleLoc Pectus Bar SystemPB10-00082026-08-21
08809986481955CastleLoc Pectus Bar SystemPB10-00092026-08-21
08809986481962CastleLoc Pectus Bar SystemPB10-00102026-08-21
08809986481979CastleLoc Pectus Bar SystemPB10-00112026-08-21
08809986481986CastleLoc Pectus Bar SystemPB10-00122026-08-21
08809986481993CastleLoc Pectus Bar SystemPB10-00132026-08-21
08809986482006CastleLoc Pectus Bar SystemPB10-00142026-08-21
08809986482013CastleLoc Pectus Bar SystemPB10-00152026-08-21
08809986482020CastleLoc Pectus Bar SystemPB10-00162026-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606168533SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168557SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168571SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168588SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168595SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168601SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168618SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168625SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168632SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168656SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168663SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168687SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168694SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168717SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168748SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168755SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168779SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168786SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168809SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168816SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168830SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168847SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168861SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168878SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168892SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168908SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168922SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168939SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606169769SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606169776SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27