SLK Evo KS5739

GUDID 05051693400788

Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 13mm (Thick)

IMPLANTS INTERNATIONAL LTD

Tibial insert

• Primary Device ID: 05051693400788
• NIH Device Record Key: 6f6353f9-f9d7-4054-8657-33b4abe1706a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SLK Evo
• Version Model Number: CR Modular (STD) Tibial insert 70mm x 13mm
• Catalog Number: KS5739
• Company DUNS: 346627222
• Company Name: IMPLANTS INTERNATIONAL LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401642769080
• Email: michael.russon@implantsinterna
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com

Device Dimensions

• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter
• Width: 70 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051693400788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980999

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/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: 2018-03-29
• Device Publish Date: 2016-07-31

On-Brand Devices [SLK Evo]

• 05051693400832: Patella Button (UHMWPE), Denoted size 38mm (Dia)
• 05051693400825: Patella Button (UHMWPE), Denoted size 36mm (Dia)
• 05051693400818: Patella Button (UHMWPE), Denoted size 34mm (Dia)
• 05051693400801: Patella Button (UHMWPE), Denoted size 32mm (Dia)
• 05051693400795: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 15mm (Thick)
• 05051693400788: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 13mm (Thick)
• 05051693400771: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 11mm (Thick)
• 05051693400764: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 9mm (Thick)
• 05051693400757: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 7mm (Thick)
• 05051693400740: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 65mm (Width), 15mm (Thick)
• 05051693400733: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 65mm (Width), 13mm (Thick)
• 05051693400726: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 65mm (Width), 11mm (Thick)
• 05051693400719: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 65mm (Width), 9mm (Thick)
• 05051693400702: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 65mm (Width), 7mm (Thick)
• 05051693400696: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 60mm (Width), 15mm (Thick)
• 05051693400689: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 60mm (Width), 13mm (Thick)
• 05051693400672: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 60mm (Width), 11mm (Thick)
• 05051693400665: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 60mm (Width), 9mm (Thick)
• 05051693400658: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 60mm (Width), 7mm (Thick)
• 05051693400641: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 55mm (Width), 15mm (Thick)
• 05051693400634: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 55mm (Width), 13mm (Thick)
• 05051693400627: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 55mm (Width), 11mm (Thick)
• 05051693400610: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 55mm (Width), 9mm (Thick)
• 05051693400603: Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 55mm (Width), 7mm (Thick)
• 05051693400597: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 70mm (Width), 15m
• 05051693400580: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 70mm (Width), 13m
• 05051693400573: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 70mm (Width), 11m
• 05051693400566: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 70mm (Width), 9mm
• 05051693400559: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 70mm (Width), 7mm
• 05051693400542: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 65mm (Width), 15m
• 05051693400535: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 65mm (Width), 13m
• 05051693400528: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 65mm (Width), 11m
• 05051693400511: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 65mm (Width), 9mm
• 05051693400504: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 65mm (Width), 7mm
• 05051693400498: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 60mm (Width), 15m
• 05051693400481: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 60mm (Width), 11m
• 05051693400474: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 60mm (Width), 11m
• 05051693400467: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 60mm (Width), 9mm
• 05051693400450: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 60mm (Width), 7mm
• 05051693400443: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 55mm (Width), 15m
• 05051693400436: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 55mm (Width), 13m
• 05051693400429: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 55mm (Width), =11
• 05051693400412: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 55mm (Width), 9mm
• 05051693400405: Cruciate Sacrificing Posterior Stabilised Tibial Insert (UHMWPE), Denoted size 55mm (Width), 7mm
• 05051693400313: Cruciate Sacrificing (Posterior Stabilised) Femoral Componant for Cemented applications (Cobalt
• 05051693400306: Cruciate Sacrificing (Posterior Stabilised) Femoral Componant for Cemented applications (Cobalt
• 05051693400290: Cruciate Sacrificing (Posterior Stabilised) Femoral Componant for Cemented applications (Cobalt
• 05051693400283: Cruciate Sacrificing (Posterior Stabilised) Femoral Componant for Cemented applications (Cobalt
• 05051693400276: Cruciate Sacrificing (Posterior Stabilised) Femoral Componant for Cemented applications (Cobalt
• 05051693400269: Cruciate Sacrificing (Posterior Stabilised) Femoral Componant for Cemented applications (Cobalt