BIOLOX FORTE 136578000

GUDID 10603295034353

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

DEPUY INTERNATIONAL LTD

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis 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