Instrument TMKTP-EXSM5

GUDID 05060296236199

Trial Tibial Plateau Plate: 5mm Extra-Small

Stanmore Implants Worldwide Ltd

Knee tibia prosthesis trial, reusable

• Primary Device ID: 05060296236199
• NIH Device Record Key: 64e83e23-28fe-4c4c-9aee-334186622ec6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instrument
• Version Model Number: tmktp/ExSm5
• Catalog Number: TMKTP-EXSM5
• Company DUNS: 494989502
• Company Name: Stanmore Implants Worldwide 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: false
• 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	05060296236199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133152

FDA Product Code

• KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Sterilization

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

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

[05060296236199]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-03-22
• Device Publish Date: 2019-07-18

On-Brand Devices [Instrument]

• 05060296236328: Passive Hinge Reamer STD
• 05060296236311: Passive Hinge Reamer SM
• 05060296236304: Passive Hinge Reamer XSM
• 05060296236175: Rotating Hinge Polyethylene Reamer: Extra-Small
• 05060296236151: Rotating Hinge Metal-Cased Reamer: Extra-Small
• 05060296233860: Rotating Hinge Polyethylene Reamer: Standard
• 05060296233846: Rotating Hinge Polyethylene Reamer: Small
• 05060296233778: Rotating Hinge Metal-Cased Reamer: Small
• 05060296233761: Rotating Hinge Metal-Cased Reamer: Standard
• 05060296233709: Fixed hinge Reamer
• 05060296236489: Customs Tibial Cutting Guide Lid
• 05060296236472: Customs Tibial Cutting Guide Tray
• 05060296236465: Insert - Extra Small Customs Tray
• 05060296236458: Base - Extra Small Customs Tray
• 05060296236441: Insert - Small Customs Tray
• 05060296236434: Base - Small Customs Tray
• 05060296236427: Common Lid - Transparent
• 05060296236410: Insert - Standard Customs Tray
• 05060296236403: Base - Standard Customs Tray
• 05060296236250: Trial Axle STD
• 05060296236243: Trial Axle SM
• 05060296236236: Trial Axle XSM
• 05060296236229: Trial Tibial Plateau Plate: 20mm Extra-Small
• 05060296236212: Trial Tibial Plateau Plate: 15mm Extra-Small
• 05060296236205: Trial Tibial Plateau Plate: 10mm Extra-Small
• 05060296236199: Trial Tibial Plateau Plate: 5mm Extra-Small
• 05060296234430: Trial Tibial Plateau Plate: 20mm Small
• 05060296234423: Trial Tibial Plateau Plate: 15mm Small
• 05060296234416: Trial Tibial Plateau Plate: 10mm Small
• 05060296234409: Trial Tibial Plateau Plate: 5mm Small
• 05060296234393: Trial Tibial Plateau Plate: 5mm Standard
• 05060296234386: Trial Tibial Plateau Plate: 10mm Standard
• 05060296234379: Trial Tibial Plateau Plate: 15mm Standard
• 05060296234362: Trial Tibial Plateau Plate: 20mm Standard
• 05060296236380: Axle cap introducer
• 05060296236373: Passive EXSM Positioning Plate: Slots
• 05060296236366: Passive SM Positioning Plate: Slots
• 05060296236359: Passive STD Positioning Plate: Slots
• 05060296236342: EXSM Positioning Plate: Slots
• 05060296236335: EXSM Positioning Plate: Holes
• 05060296236168: Cutting Guide Fixation Pin
• 05060296236137: Bush Compressor: Extra-Small
• 05060296236120: Face Cutter Body & Spigot
• 05060296236113: Alignment Tool 50, 70, & 90mm
• 05060296233822: Tibial Cutting Guide: Prongs
• 05060296233815: Tibial Cutting Guide: Rest
• 05060296233808: Tibial Cutting Guide: Rod
• 05060296233747: STD Positioning Plate: Slots
• 05060296233730: STD Positioning Plate: Holes
• 05060296233723: SM Positioning Plate: Slots