NovoHip Total Hip System 1435-2803

GUDID 00811382034282

Adapter, Trial 16/18 - 12/14 L

NOVOSOURCE, LLC

Femoral head prosthesis trial

• Primary Device ID: 00811382034282
• NIH Device Record Key: d96a453e-b516-492a-bbfc-3c6145bd31bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovoHip Total Hip System
• Version Model Number: 1435-2803
• Catalog Number: 1435-2803
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811382034282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132158

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

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

[00811382034282]

Moist Heat or Steam Sterilization

[00811382034282]

Moist Heat or Steam Sterilization

[00811382034282]

Moist Heat or Steam Sterilization

[00811382034282]

Moist Heat or Steam Sterilization

[00811382034282]

Moist Heat or Steam Sterilization

[00811382034282]

Moist Heat or Steam Sterilization

[00811382034282]

Moist Heat or Steam Sterilization

[00811382034282]

Moist Heat or Steam Sterilization

[00811382034282]

Moist Heat or Steam Sterilization

[00811382034282]

Moist Heat or Steam Sterilization

[00811382034282]

Moist Heat or Steam Sterilization

[00811382034282]

Moist Heat or Steam Sterilization

[00811382034282]

Moist Heat or Steam Sterilization

[00811382034282]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-16
• Device Publish Date: 2018-02-27

On-Brand Devices [NovoHip Total Hip System]

• 00811382037122: Liner, Elevated Face Sz 58x36
• 00811382037115: Liner, Neutral Face Sz 58x36
• 00811382037108: Taper Stem, Ext Offset Sz 16.25
• 00811382037092: Taper Stem, Std Offset Sz 16.25
• 00811382037085: NH Bi-Polar Trial Case
• 00811382037078: NH Hemis Reamer Case
• 00811382037061: NH Acetabular Prep Case
• 00811382037054: NH Femoral Prep Case
• 00811382034664: Handle, Straight Reamer
• 00811382034602: Flex Depth Gage
• 00811382034565: Handle, Head Impactor
• 00811382034503: Hemispherical Reamer Sz 63
• 00811382034428: Hemispherical Reamer Sz 53
• 00811382034367: Hemispherical Reamer Sz 47
• 00811382034336: Head Impactor Sz 40
• 00811382034299: Adapter, Trial 16/18 - 12/14 XL
• 00811382034282: Adapter, Trial 16/18 - 12/14 L
• 00811382034275: Adapter, Trial 16/18 - 12/14 M
• 00811382034268: Adapter, Trial 16/18 - 12/14 S
• 00811382034251: Trial Neck, Ext Sz 7.5 - 22.5
• 00811382034244: Trial Liner, Elevated Face Sz 66x40
• 00811382034237: Trial Liner, Elevated Face Sz 66x32
• 00811382034220: Trial Liner, Elevated Face Sz 66x28
• 00811382034213: Trial Liner, Elevated Face Sz 62x40
• 00811382034206: Trial Liner, Elevated Face Sz 62x32
• 00811382034190: Trial Liner, Elevated Face Sz 62x28
• 00811382034183: Trial Liner, Elevated Face Sz 58x40
• 00811382034176: Trial Liner, Elevated Face Sz 58x32
• 00811382034169: Trial Liner, Elevated Face Sz 58x28
• 00811382034152: Trial Liner, Elevated Face Sz 54x36
• 00811382034145: Trial Liner, Elevated Face Sz 54x32
• 00811382034138: Trial Liner, Elevated Face Sz 54x28
• 00811382034121: Trial Liner, Elevated Face Sz 52x36
• 00811382034114: Trial Liner, Elevated Face Sz 52x32
• 00811382034107: Trial Liner, Elevated Face Sz 52x28
• 00811382034091: Trial Liner, Elevated Face Sz 50x32
• 00811382034084: Trial Liner, Elevated Face Sz 50x28
• 00811382034077: Trial Liner, Elevated Face Sz 46x28
• 00811382034060: Femoral Option Head, Trial Sz 40
• 00811382034053: Femoral Option Head, Trial Sz 36
• 00811382034046: Femoral Option Head, Trial Sz 32
• 00811382034039: Femoral Option Head, Trial Sz 28
• 00811382034022: Trial Liner, Elevated Face Sz 66x40
• 00811382034015: Trial Liner, Elevated Face Sz 66x32
• 00811382034008: Trial Liner, Elevated Face Sz 66x28
• 00811382033995: Trial Liner, Elevated Face Sz 62x40
• 00811382033988: Trial Liner, Elevated Face Sz 62x32
• 00811382033971: Trial Liner, Elevated Face Sz 62x28
• 00811382033964: Trial Liner, Elevated Face Sz 58x40
• 00811382033957: Trial Liner, Elevated Face Sz 58x32