BIOLOX FORTE 136578000

GUDID 10603295034353

BIOLOX FORTE CERAMIC FEMORAL HEAD +9 Diameter 32mm 12/14 TAPER

DEPUY INTERNATIONAL LTD

Ceramic femoral head prosthesis

• Primary Device ID: 10603295034353
• NIH Device Record Key: 088f8a78-d100-4aac-8a49-7587b1ad2b17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOLOX FORTE
• Version Model Number: 1365-78-000
• Catalog Number: 136578000
• Company DUNS: 896498813
• Company Name: DEPUY INTERNATIONAL LTD
• 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: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295034353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K891083

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: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-11-06

On-Brand Devices [BIOLOX FORTE]

• 10603295034353: BIOLOX FORTE CERAMIC FEMORAL HEAD +9 Diameter 32mm 12/14 TAPER
• 10603295034346: BIOLOX FORTE CERAMIC FEMORAL HEAD +5 Diameter 32mm 12/14 TAPER
• 10603295034339: BIOLOX FORTE CERAMIC FEMORAL HEAD +1 Diameter 32mm 12/14 TAPER