FDA.reportPublic FDA data

LINK Instruments - Fixation instruments

Primary DI
04026575436828
Brand
LINK Instruments - Fixation instruments
Company
WALDEMAR LINK GmbH & Co. KG
Model
319-582/00
Device description
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile - General Instrument
Published
2022-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HXQCRIMPER, PIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXQCrimper, PinOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575436828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575436828040265754368284026575436828

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315675488
Device count
1
Premarket 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
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04026575431557LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
04026575431564LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXQ2023-01-11
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