SAIPH® 293-724

GUDID 05055455519497

Saiph® Trial Bearing Red. Left.10mm

MATORTHO LTD

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 05055455519497
• NIH Device Record Key: 89d10f77-1c5e-4eb6-8f85-105fe0775137
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAIPH®
• Version Model Number: 293-724
• Catalog Number: 293-724
• Company DUNS: 216819863
• Company Name: MATORTHO LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055455519497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140222

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

[05055455519497]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-25
• Device Publish Date: 2021-01-15

On-Brand Devices [SAIPH®]

• 05055455518001: Femoral Trial Left, Size 1. Reusable Class IIa instruments use for SAIPH® Knee System. Surgica
• 05055455519503: Saiph® Trial Bearing Red. Left.12mm
• 05055455519497: Saiph® Trial Bearing Red. Left.10mm
• 05055455519435: Saiph® Trial Bearing Yellow. Right.10mm
• 05055455519428: Saiph® Trial Bearing Yellow. Left.20mm
• 05055455519411: Saiph® Trial Bearing Yellow. Left.18mm
• 05055455519404: Saiph® Trial Bearing Yellow. Left.16mm
• 05055455519398: Saiph® Trial Bearing Yellow. Left.14mm
• 05055455519381: Saiph® Trial Bearing Yellow. Left.12mm
• 05055455519374: Saiph® Trial Bearing Yellow. Left.10mm
• 05055455518803: Tibial Webbing Chisel Guide C to F
• 05055455518797: Tibial Webbing Chisel Guide A to B
• 05055455518773: Variable Spacer
• 05055455518759: Tibial Webbing Chisel Size 6
• 05055455518742: Tibial Webbing Chisel Size 5
• 05055455518735: Tibial Webbing Chisel Size 4
• 05055455518728: Tibial Webbing Chisel Size 3
• 05055455518711: Tibial Webbing Chisel Size 2
• 05055455518704: Tibial Webbing Chisel Size 1
• 05055455518698: Saiph® Femoral Impactor
• 05055455518681: Saiph® Femoral Spacer. Green
• 05055455518674: Saiph® Femoral Spacer. Blue
• 05055455518667: Saiph® Femoral Spacer. Red
• 05055455518650: Saiph® Femoral Spacer. Yellow
• 05055455518568: Dual Ended Tibial Spacer. 20 mm
• 05055455518551: Dual Ended Tibial Spacer. 18 mm
• 05055455518544: Dual Ended Tibial Spacer. 16 mm
• 05055455518537: Dual Ended Tibial Spacer. 14 mm
• 05055455518520: Dual Ended Tibial Spacer. 12 mm
• 05055455518513: Dual Ended Tibial Spacer . 10 mm
• 05055455518483: Tibial Drill Guide Size F
• 05055455518476: Tibial Drill Guide Size E
• 05055455518469: Tibial Drill Guide Size D
• 05055455518452: Tibial Drill Guide Size C
• 05055455518445: Tibial Drill Guide Size B
• 05055455518438: Tibial Drill Guide Size A
• 05055455518421: Tibial Template Size F
• 05055455518414: Tibial Template Size E
• 05055455518407: Tibial Template Size D
• 05055455518391: Tibial Template Size C
• 05055455518384: Tibial Template Size B
• 05055455518377: Tibial Template Size A
• 05055455518339: Femoral Component Inserter / Remover Support - Green
• 05055455518322: Femoral Component Inserter / Remover Support - Blue
• 05055455518315: Femoral Component Inserter / Remover Support - Red
• 05055455518308: Femoral Component Inserter / Remover Support - Yellow.
• 05055455518292: Femoral Component Inserter / Remover
• 05055455518117: Femoral Trial Right, Size 4
• 05055455518032: Femoral Trial Left, Size 4
• 05055455518025: Femoral Trial Left, Size 3