Ceramic Femoral Head WE-1-1010

GUDID B046WE110100

Ceramic Femoral Head 32mm 0.0mm

SIGNAL MEDICAL CORPORATION

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: B046WE110100
• NIH Device Record Key: ff9435d6-9b96-4852-9547-1aabad62400b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramic Femoral Head
• Version Model Number: 32mm 0.0mm
• Catalog Number: WE-1-1010
• Company DUNS: 169289308
• Company Name: SIGNAL MEDICAL CORPORATION
• 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: true
• 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: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B046WE110100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971721

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: 2018-07-06
• Device Publish Date: 2016-06-09

On-Brand Devices [Ceramic Femoral Head]

• B046WE110110: Ceramic Femoral Head 32mm +3.5mm
• B046WE110100: Ceramic Femoral Head 32mm 0.0mm
• B046WE110090: Ceramic Femoral Head 32mm -3.5mm
• B046WE110080: Ceramic Femoral Head 28mm +3.5