Stanmore JTSDF-R-XSM

GUDID 05060296236052

JTS Distal Femur Right XSM

Stanmore Implants Worldwide Ltd

Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic

• Primary Device ID: 05060296236052
• NIH Device Record Key: ce617dd4-ca70-48b4-b223-4f442d99a263
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stanmore
• Version Model Number: JTSDF-R-XSM
• Catalog Number: JTSDF-R-XSM
• Company DUNS: 494989502
• Company Name: Stanmore Implants Worldwide Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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 Dimensions

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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060296236052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092138

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-07-18

On-Brand Devices [Stanmore]

• 05060296233167: Bumper Pad XSM
• 05060296233150: Bushes XSM
• 05060296233136: Axle Cap
• 05060296232825: Tibial Rotating Hinge Passive Bearing SM
• 05060296232818: Tibial Rotating Hinge Passive Bearing XSM
• 05060296232023: Circlip
• 05060296232016: Bushes STD
• 05060296232009: Bushes SM
• 05060296231996: Bumper Pad STD
• 05060296231989: Bumper Pad SM
• 05060296236106: JTS Distal Femur Left STD
• 05060296236090: JTS Distal Femur Left SM
• 05060296236083: JTS Distal Femur Left XSM
• 05060296236076: JTS Distal Femur Right STD
• 05060296236069: JTS Distal Femur Right SM
• 05060296236052: JTS Distal Femur Right XSM
• 05060296232832: Tibial Rotationg Hinge Passive Bearing STD
• 05060296235970: Tibial Rotating Hinge Metal Cased Bearing XSM
• 05060296232849: Tibial Rotating Hinge Poly Cased Bearing XSM
• 05060296232061: Tibial Rotating Hinge Poly Cased Bearing STD
• 05060296232054: Tibial Rotating Hinge Poly Cased Bearing SM
• 05060296232047: Tibial Rotating Hinge Metal Cased Bearing STD
• 05060296232030: Tibial Rotating Hinge Metal Cased Bearing SM
• 05060296230340: Tibial Plateau Plate STD 20mm
• 05060296230333: Tibial Plateau Plate STD 15mm
• 05060296230326: Tibial Plateau Plate STD 10mm
• 05060296230319: Tibial Plateau Plate STD 5mm
• 05060296230302: Tibial Plateau Plate SM 20mm
• 05060296230296: Tibial Plateau Plate SM 15mm
• 05060296230289: Tibial Plateau Plate SM 10mm
• 05060296230272: Tibial Plateau Plate SM 5mm