Cermet Series III AL3962

GUDID 05051693311121

Acetabular Liner for Acetabular Shell ( 36mm Head) (UHMWPE) 10 Deg. Hood 64/66 x 52mm

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: 05051693311121
• NIH Device Record Key: 080a54ad-2c4e-4e02-bae0-7b8d2f472e96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cermet Series III
• Version Model Number: 10 Deg. Hood Acetabular Liner 64/66 x 52mm - 36mm
• Catalog Number: AL3962
• 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: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 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	05051693311121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071583

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

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 [Cermet Series III]

• 05051693311121: Acetabular Liner for Acetabular Shell ( 36mm Head) (UHMWPE) 10 Deg. Hood 64/66 x 52mm
• 05051693311114: Acetabular Liner for Acetabular Shell ( 36mm Head) (UHMWPE) 10 Deg. Hood 58/60/62 x 48mm
• 05051693311107: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) 10 Deg. Hood 64/66 x 52mm
• 05051693311091: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) 10 Deg. Hood 58/60/62 x 48mm
• 05051693311084: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) 10 Deg. Hood 54/56 x 44mm
• 05051693311077: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) 10 Deg. Hood 52 x 41mm
• 05051693311060: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) 10 Deg. Hood 64/66 x 52mm
• 05051693311053: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) 10 Deg. Hood 58/60/62 x 48mm
• 05051693311046: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) 10 Deg. Hood 54/56 x 39mm
• 05051693311039: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) 10 Deg. Hood 52 x 41mm
• 05051693311022: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) 10 Deg. Hood 46/48/50 x 39mm
• 05051693311015: Acetabular Liner for Acetabular Shell ( 36mm Head) (UHMWPE) Neutral 64/66 x 52mm
• 05051693311008: Acetabular Liner for Acetabular Shell ( 36mm Head) (UHMWPE) Neutral 58/60/62 x 48mm
• 05051693310995: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) Neutral 64/66 x 52mm
• 05051693310988: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) Neutral 58/60/62 x 48mm
• 05051693310971: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) Neutral 54/56 x 44mm
• 05051693310964: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) Neutral 52 x 41mm
• 05051693310957: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) Neutral64/66 x 48mm
• 05051693310940: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) Neutral 58/60/62 x 48mm - 28mm Head
• 05051693310933: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) Neutral 54/56 x44mm - 28mm
• 05051693310926: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) Neutral 52 x 41mm
• 05051693310919: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) Neutral
• 05051693310902: Ceramic Liner for Acetabular Shell ( 36mm Head) (Ceramic) 64/66 x 52mm
• 05051693310896: Ceramic Liner for Acetabular Shell ( 36mm Head) (Ceramic) 58/60/62 x 48mm
• 05051693310889: Ceramic Liner for Acetabular Shell ( 36mm Head) (Ceramic) 54/56 x 44mm - 36mm
• 05051693310872: Ceramic Liner for Acetabular Shell ( 32mm Head) (Ceramic) 64/66 x 52mm
• 05051693310865: Ceramic Liner for Acetabular Shell ( 32mm Head) (Ceramic) 58/60/62 x 48mm
• 05051693310858: Ceramic Liner for Acetabular Shell ( 32mm Head) (Ceramic) 54/56 x 44mm
• 05051693310841: Ceramic Liner for Acetabular Shell ( 28mm Head) (Ceramic) 52 x 41mm
• 05051693310834: Ceramic Liner for Acetabular Shell ( 28mm Head) (Ceramic) 64/66 x 52mm
• 05051693310827: Ceramic Liner for Acetabular Shell ( 28mm Head) (Ceramic) 58/60/62 x 48mm
• 05051693310810: Ceramic Liner for Acetabular Shell ( 28mm Head) (Ceramic) 54/56 x 44mm
• 05051693310803: Ceramic Liner for Acetabular Shell ( 28mm Head) (Ceramic) 52 x 41mm
• 05051693310797: Ceramic Liner for Acetabular Shell ( 28mm Head) (Ceramic) 46/48/50 x 39mm
• 05051693310780: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 66mm (Dia)
• 05051693310773: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 64mm (Dia)
• 05051693310766: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 62mm (Dia)
• 05051693310759: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 60mm (Dia)
• 05051693310742: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 58mm (Dia)
• 05051693310735: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 56mm (Dia)
• 05051693310728: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 54mm (Dia)
• 05051693310711: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 52mm (Dia)
• 05051693310704: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 50mm (Dia)
• 05051693310698: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 48mm (Dia)
• 05051693310681: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 46mm (Dia)