Quatro-M Femoral Stem WK-1-1014

GUDID B046WK110140

Quatro-M Femoral Stem 3M

SIGNAL MEDICAL CORPORATION

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: B046WK110140
• NIH Device Record Key: 2167fb2d-453f-4094-a9f5-7ada04e82d2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quatro-M Femoral Stem
• Version Model Number: 3M
• Catalog Number: WK-1-1014
• 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	B046WK110140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033313

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 2016-03-24

On-Brand Devices [Quatro-M Femoral Stem]

• B046WK110330: Quatro-M Femoral Stem 4XS
• B046WK110320: Quatro-M Femoral Stem 3XS
• B046WK110310: Quatro-M Femoral Stem 2XS
• B046WK110230: Quatro-M Femoral Stem 5L
• B046WK110220: Quatro-M Femoral Stem 5M
• B046WK110210: Quatro-M Femoral Stem 5S
• B046WK110200: Quatro-M Femoral Stem 4XL
• B046WK110190: Quatro-M Femoral Stem 4L
• B046WK110170: Quatro-M Femoral Stem 4S
• B046WK110160: Quatro-M Femoral Stem 3XL
• B046WK110150: Quatro-M Femoral Stem 3L
• B046WK110140: Quatro-M Femoral Stem 3M
• B046WK110130: Quatro-M Femoral Stem 3S
• B046WK11011: Quatro-M Femoral Stem 2L
• B046WK11010: Quatro-M Femoral Stem 2M
• B046WK110090: Quatro-M Femoral Stem 2S
• B046WK110340: Quatro-M Femoral Stem 5XS
• B046WK110180: Quatro-M Femoral Stem 4M
• B046WK110240: Quatro-M Femoral Stem 5XL
• B046WK110120: Quatro-M Femoral Stem 2XL