FDA.reportPublic FDA data

LINK Instrument

Primary DI
04026575259434
Brand
LINK Instrument
Company
WALDEMAR LINK GmbH & Co. KG
Model
136-225/00
Catalog number
136-225/00
Device description
Screw
Published
2019-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183141000LINK MP Monoblock Hip ProsthesisWaldemar Link GmbH & Co. KG2019-02-08LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575259434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575259434040265752594344026575259434

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315675488
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
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
07611996118674POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142327POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142341POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142358POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142396POLARSTEMSmith & Nephew, Inc.LZO2016-09-01
07611996074918SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074932SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074970SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075007SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075014SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075021SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075038SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095586SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095593SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095609SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095616SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095623SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095630SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095647SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095654SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095661SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095678SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095685SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996103410POLARSTEMSmith & Nephew, Inc.LZO2016-07-25
07611996103427POLARSTEMSmith & Nephew, Inc.LZO2016-07-25