Novosource Total Hip System 1280-5836

GUDID 00811382037511

Liner, Elevated Face Sz 58/60 x36

NOVOSOURCE, LLC

Constrained polyethylene acetabular liner

• Primary Device ID: 00811382037511
• NIH Device Record Key: 4613b5a4-82ef-4e26-9356-416c0a67dfa8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novosource Total Hip System
• Version Model Number: 1280-5836
• Catalog Number: 1280-5836
• Company DUNS: 081034828
• Company Name: NOVOSOURCE, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx
• Phone: 3045542167
• Email: xx@xx.xx

Device Dimensions

• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 58 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811382037511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140701

FDA Product Code

• OQG: Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-18
• Device Publish Date: 2019-12-10

On-Brand Devices [Novosource Total Hip System]

• 00811382031656: Liner, Elevated Face Sz 62x40
• 00811382031649: Liner, Elevated Face Sz 58x40
• 00811382031625: Liner, Elevated Face Sz 52x32
• 00811382031441: Femoral Head, Ceramic Sz 28
• 00811382031359: Femoral Head, Ceramic Sz 32 XL
• 00811382031328: Femoral Head, Ceramic Sz 32 S
• 00811382031304: Femoral Head, Ceramic Sz 28 M
• 00811382031144: Femoral Head, CoCr Sz 32 M
• 00811382031137: Femoral Head, CoCr Sz 32 S
• 00811382030710: Acetabular Shell, Polar Hole Sz 50
• 00811382030703: Acetabular Shell, Polar Hole Sz 48
• 00811382030673: Liner, Elevated Face Sz 66x32
• 00811382030611: Liner, Elevated Face Sz 58x32
• 00811382030543: Liner, Elevated Face Sz 52x28
• 00811382030468: Liner, Neutral Face Sz 62x32
• 00811382030451: Liner, Neutral Face Sz 62x28
• 00811382030420: Liner, Neutral Face Sz 58x28
• 00811382030413: Liner, Neutral Face Sz 54x36
• 00811382030406: Liner, Neutral Face Sz 54x32
• 00811382030345: Liner, Neutral Face Sz 50x28
• 00811382030161: Taper Stem, Ext Offset Sz 13.75
• 00811382030116: Taper Stem, Ext Offset Sz 7.5
• 00811382030062: Taper Stem, Std Offset Sz 13.75
• 00811382030017: Taper Stem, Std Offset Sz 7.5
• 00811382037535: Liner, Elevated Face Sz 66/68 x36
• 00811382037528: Liner, Elevated Face Sz 62/64 x36
• 00811382037511: Liner, Elevated Face Sz 58/60 x36
• 00811382037504: Liner, Elevated Face Sz 54/56 x36
• 00811382037498: Liner, Elevated Face Sz 52x36
• 00811382037481: Liner, Elevated Face Sz 52x32
• 00811382037474: Liner, Elevated Face Sz 50x32
• 00811382037467: Liner, Elevated Face Sz 46/48 x28
• 00811382037450: Liner, Neutral Face Sz 66/68 x36
• 00811382037443: Liner, Neutral Face Sz 62/64 x36
• 00811382037436: Liner, Neutral Face Sz 58/60 x36
• 00811382037429: Liner, Neutral Face Sz 54/56 x36
• 00811382037412: Liner, Neutral Face Sz 52x36
• 00811382037405: Liner, Neutral Face Sz 52x32
• 00811382037399: Liner, Neutral Face Sz 50x32
• 00811382037382: Liner, Neutral Face Sz 46/48x28
• 00811382031281: Femoral Head, CoCr Sz 40
• 00811382031274: Femoral Head, CoCr Sz 36
• 00811382031267: Femoral Head, CoCr Sz 32
• 00811382031250: Femoral Head, CoCr Sz 28
• 00811382031243: Femoral Head, CoCr Sz 40 XL
• 00811382031236: Femoral Head, CoCr Sz 40 L
• 00811382031229: Femoral Head, CoCr Sz 40 M
• 00811382031212: Femoral Head, CoCr Sz 40 S
• 00811382031205: Femoral Head, CoCr Sz 36 XL
• 00811382031199: Femoral Head, CoCr Sz 36 L