C2 Hip 9045.16.013

GUDID 08033390071666

C2 Hip - Lateralized Trial Neck

LIMACORPORATE SPA

Femoral stem prosthesis trial

• Primary Device ID: 08033390071666
• NIH Device Record Key: 8a141470-c4df-4b2e-b58e-bc75b78140a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C2 Hip
• Version Model Number: 9045.16.013
• Catalog Number: 9045.16.013
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390071666 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170473

FDA Product Code

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

Sterilization

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

[08033390071666]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-05
• Device Publish Date: 2018-03-13

On-Brand Devices [C2 Hip]

• 08033390071673: M8 Stem Beater-Extractor
• 08033390071666: C2 Hip - Lateralized Trial Neck
• 08033390071659: C2 Hip - Trial Neck
• 08033390066594: C2 Hip - Broach # 6
• 08033390066556: C2 Hip - Broach # 2
• 08033390066549: C2 Hip - Broach # 1
• 08033390066532: C2 Hip - Broach # 0
• 08033390066525: C2 Hip - Broach # 01
• 08033390066655: C2 Hip - Broach # 12
• 08033390066648: C2 Hip - Broach # 11
• 08033390066631: C2 Hip - Broach # 10
• 08033390066624: C2 Hip - Broach # 9