Novosource Total Hip System 1215-6628

GUDID 00811382030963

Liner, Elevated Face Sz 66x28

NOVOSOURCE, LLC

Constrained polyethylene acetabular liner

• Primary Device ID: 00811382030963
• NIH Device Record Key: dabec1c2-4cee-43f1-bcbe-68c7e07eb074
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novosource Total Hip System
• Version Model Number: 1215-6628
• Catalog Number: 1215-6628
• 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

Device Dimensions

• Lumen/Inner Diameter: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811382030963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140701

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-11
• Device Publish Date: 2018-02-27

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