FDA.reportPublic FDA data

AccelFix Lumbar Plate System

Primary DI
08800061642599
Brand
AccelFix Lumbar Plate System
Company
L&K BIOMED CO. ,LTD.
Model
7101-5535
Device description
AccelFix Lumbar Plate Screw, (Fixed type, Cancellous), ø5.5, 35mm
Published
2026-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192481000AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.2020-07-28KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800061642599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800061642599088000616425998800061642599

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

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
08809986491008BluEX Cervical Expandable Cage System1417-1000S2026-06-04
08809986491015BluEX Cervical Expandable Cage System1417-1100S2026-06-04
08809986491022BluEX Cervical Expandable Cage System1417-1200S2026-06-04
08809986491039BluEX Cervical Expandable Cage System1417-1300S2026-06-04
08809986491046BluEX Cervical Expandable Cage System1417-0407S2026-06-04
08809986491053BluEX Cervical Expandable Cage System1417-0507S2026-06-04
08809986491060BluEX Cervical Expandable Cage System1417-0607S2026-06-04
08809986491077BluEX Cervical Expandable Cage System1417-0707S2026-06-04
08809986491084BluEX Cervical Expandable Cage System1417-0807S2026-06-04
08809986491091BluEX Cervical Expandable Cage System1417-0907S2026-06-04
08809986491107BluEX Cervical Expandable Cage System1417-1007S2026-06-04
08809986491114BluEX Cervical Expandable Cage System1417-1107S2026-06-04
08809986491121BluEX Cervical Expandable Cage System1417-1207S2026-06-04
08809986491138BluEX Cervical Expandable Cage System1417-1307S2026-06-04
08809986491145CastleLoc-P Anterior Cervical Plate System6911-17152026-06-04
08809986491152CastleLoc-P Anterior Cervical Plate System6911-17172026-06-04
08809986491169CastleLoc-P Anterior Cervical Plate System6911-17192026-06-04
08809986491176CastleLoc-P Anterior Cervical Plate System6911-17212026-06-04
08809986491183CastleLoc-P Anterior Cervical Plate System6911-17232026-06-04
08809986491190CastleLoc-P Anterior Cervical Plate System6911-17252026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017913664Saber-C Body (PT), 12x15x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.KWQ2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.KWQ2026-06-05
00840283407949VyPlate™VY SPINE LLCKWQ2026-06-05
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