Rim-Fix AL3753

GUDID 05051693307926

Poly Liner Neutral 54 x 28mm (UHMWPE) Uncemented

IMPLANTS INTERNATIONAL LTD

Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner

• Primary Device ID: 05051693307926
• NIH Device Record Key: 6ecaba69-65bd-4f8b-b19a-29e84112da7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rim-Fix
• Version Model Number: Poly Liner Neutral 54 x 28mm
• Catalog Number: AL3753
• 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

• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 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	05051693307926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993713

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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 [Rim-Fix]

• 05051693309814: ACETABULAR DUAL COATED CUP UNCEMENTED -66mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309807: ACETABULAR DUAL COATED CUP UNCEMENTED -64mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309791: ACETABULAR DUAL COATED CUP UNCEMENTED -62mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309784: ACETABULAR DUAL COATED CUP UNCEMENTED -60mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309777: ACETABULAR DUAL COATED CUP UNCEMENTED -58mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309760: ACETABULAR DUAL COATED CUP UNCEMENTED -56mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309753: ACETABULAR DUAL COATED CUP UNCEMENTED -54mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309746: ACETABULAR DUAL COATED CUP UNCEMENTED -52mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309739: ACETABULAR DUAL COATED CUP UNCEMENTED -50mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309722: ACETABULAR DUAL COATED CUP UNCEMENTED -48mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309715: ACETABULAR DUAL COATED CUP UNCEMENTED -46mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309708: PLASMA COATED ACETABULAR CUP - 66mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309692: PLASMA COATED ACETABULAR CUP - 64mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309685: PLASMA COATED ACETABULAR CUP - 62mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309678: PLASMA COATED ACETABULAR CUP - 60mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309661: PLASMA COATED ACETABULAR CUP - 58mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309654: PLASMA COATED ACETABULAR CUP - 56mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309647: PLASMA COATED ACETABULAR CUP - 54mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309630: PLASMA COATED ACETABULAR CUP - 52mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309623: PLASMA COATED ACETABULAR CUP - 50mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309616: PLASMA COATED ACETABULAR CUP - 48mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309609: PLASMA COATED ACETABULAR CUP - 46mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309593: Poly Liner Neutral 66 x 32mm (UHMWPE) Uncemented
• 05051693309579: Poly Liner Neutral 64 x 32mm (UHMWPE) Uncemented
• 05051693309135: Poly Liner 10° Hood 66 x 32mm (UHMWPE) Uncemented
• 05051693309128: Poly Liner 10° Hood 64 x 32mm (UHMWPE) Uncemented
• 05051693309111: Poly Liner 10° Hood 66 x 28mm (UHMWPE) Uncemented
• 05051693309104: Poly Liner 10° Hood 64 x 28mm (UHMWPE) Uncemented
• 05051693309098: Poly Liner 10° Hood 66 x 36mm (UHMWPE) Uncemented
• 05051693309081: Poly Liner 10° Hood 64 x 36mm (UHMWPE) Uncemented
• 05051693309074: Poly Liner 10° Hood 62 x 36mm (UHMWPE) Uncemented
• 05051693309067: Poly Liner 10° Hood 60 x 36mm (UHMWPE) Uncemented
• 05051693309050: Poly Liner 10° Hood 58 x 36mm (UHMWPE) Uncemented
• 05051693309043: Poly Liner 10° Hood 56 x 36mm (UHMWPE) Uncemented
• 05051693309036: Poly Liner 10° Hood 54 x 36mm (UHMWPE) Uncemented
• 05051693309029: Poly Liner 10° Hood 52 x 36mm (UHMWPE) Uncemented
• 05051693309012: Poly Liner 10° Hood 50 x 36mm (UHMWPE) Uncemented
• 05051693308992: Poly Liner Neutral 66 x 36mm (UHMWPE) Uncemented
• 05051693308985: Poly Liner Neutral 64 x 36mm (UHMWPE) Uncemented
• 05051693308978: Poly Liner Neutral 62 x 36mm (UHMWPE) Uncemented
• 05051693308961: Poly Liner Neutral 60 x 36mm (UHMWPE) Uncemented
• 05051693308954: Poly Liner Neutral 58 x 36mm (UHMWPE) Uncemented
• 05051693308947: Poly Liner Neutral 56 x 36mm (UHMWPE) Uncemented
• 05051693308930: Poly Liner Neutral 54 x 36mm (UHMWPE) Uncemented
• 05051693308923: Poly Liner Neutral 52 x 36mm (UHMWPE) Uncemented
• 05051693308916: Poly Liner Neutral 50 x 36mm (UHMWPE) Uncemented
• 05051693308909: Poly Liner 10° Hood 46 x 32mm (UHMWPE) Uncemented
• 05051693308893: Poly Liner 10° Hood 46 x 28mm (UHMWPE) Uncemented
• 05051693308206: Poly Liner 10° Hood 62 x 32mm (UHMWPE) Uncemented
• 05051693308190: Poly Liner 10° Hood 60 x 32mm (UHMWPE) Uncemented