FDA.reportPublic FDA data

FacetLink System

Primary DI
04026575420841
Brand
FacetLink System
Company
WALDEMAR LINK GmbH & Co. KG
Model
80-1010/35
Catalog number
80-1010/35
Device description
Facet Screw
Published
2015-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MRWSystem, Facet Screw Spinal Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123497000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123497000FACET SCREW SYSTEMFacet-Link, Inc.2013-02-28MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575420841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575420841040265754208414026575420841

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, sterile, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold plates, or other stabilization device, to bone; 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). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315675488
Device count
1
DM exempt
true
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
04026575083237Endo-Model Knee System - EVO Knee System - OptiStem Instr151-16/16151-16/162026-05-15
04026575083282Endo-Model Knee System - EVO Knee System - OptiStem Instr151-17/17151-17/172026-05-15
04026575083329Endo-Model Knee System - EVO Knee System - OptiStem Instr151-18/18151-18/182026-05-15
04026575083404Endo-Model Knee System - EVO Knee System - OptiStem Instr151-19/19151-19/192026-05-15
04026575083503Endo-Model Knee System - EVO Knee System - OptiStem Instr151-20/20151-20/202026-05-15
04026575083640Endo-Model Knee System - EVO Knee System - OptiStem Instr151-21/21151-21/212026-05-15
04026575083732Endo-Model Knee System - EVO Knee System - OptiStem Instr151-04/04151-04/042026-05-15
04026575092307LinkSymphoKnee - Instruments151-09/09151-09/092026-05-15
04026575092321LinkSymphoKnee - Instruments151-10/10151-10/102026-05-15
04026575092345LinkSymphoKnee - Instruments151-11/11151-11/112026-05-15
04026575092352Endo-Model Knee System - EVO Knee System - OptiStem Instr151-12/12151-12/122026-05-15
04026575092437Endo-Model Knee System - EVO Knee System - OptiStem Instr151-13/13151-13/132026-05-15
04026575093014Endo-Model Knee System - EVO Knee System - OptiStem Instr151-14/14151-14/142026-05-15
04026575093021Endo-Model Knee System - EVO Knee System - OptiStem Instr151-15/15151-15/152026-05-15
04026575048168General Instrument15-80352026-02-02
04026575080106MP Reconstruction System Instruments134-011/002026-02-02
04026575080175MP Reconstruction System Instruments134-031/002026-02-02
04026575080182General Instrument134-210/002026-02-02
04026575081011MP Reconstruction System - Instruments134-212/002026-02-02
04026575081042MP Reconstruction System Instruments134-041/002026-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800039819909FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819916FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819923FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819930FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819947FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819954FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819961FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819978FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819985FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819992FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820004FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820011FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820028FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820035FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820042FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820059FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820318FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820325FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820332FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820349FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039821391FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823739FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823746FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823753FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823760FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823777FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823784FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823791FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823807FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823814FasetDIOMEDICAL CO.,LTD.MRW2019-02-08