BIOLOX 170-36-03

GUDID 10885862658449

BIOLOX®delta Femoral Head: 36mm O.D., +3.5mm, 12/14

Exactech, Inc.

Ceramic femoral head prosthesis

• Primary Device ID: 10885862658449
• NIH Device Record Key: 37318c52-443c-41ad-8287-d5214441b6f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOLOX
• Version Model Number: 170-36-03
• Catalog Number: 170-36-03
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• 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: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862658449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103012

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-11-24
• Device Publish Date: 2025-11-14

On-Brand Devices [BIOLOX]

• 10885862658500: BIOLOX®Option Adapter: -3.5mm, 12/14
• 10885862658494: BIOLOX®Option Adapter: +3.5mm, 12/14
• 10885862658487: BIOLOX®Option Adapter: +0mm, 12/14
• 10885862658470: BIOLOX®delta Femoral Head: 36mm O.D., -3.5mm, 12/14
• 10885862658463: BIOLOX®Option Femoral Head: 36mm O.D.
• 10885862658456: BIOLOX®delta Femoral Head: 36mm O.D., +7mm, 12/14
• 10885862658449: BIOLOX®delta Femoral Head: 36mm O.D., +3.5mm, 12/14
• 10885862658432: BIOLOX®delta Femoral Head: 36mm O.D., +0mm, 12/14
• 10885862658425: BIOLOX®delta Femoral Head: 32mm O.D., -3.5mm, 12/14
• 10885862658418: BIOLOX®Option Femoral Head: 32mm O.D.
• 10885862658401: BIOLOX®delta Femoral Head: 32mm O.D., +7mm, 12/14
• 10885862658395: BIOLOX®delta Femoral Head: 32mm O.D., +3.5mm, 12/14
• 10885862658388: BIOLOX®delta Femoral Head: 32mm O.D., +0mm, 12/14
• 10885862658371: BIOLOX®delta Femoral Head: 28mm O.D., -3.5mm, 12/14
• 10885862658364: BIOLOX®Option Femoral Head: 28mm O.D.
• 10885862658357: BIOLOX®delta Femoral Head: 28mm O.D., +3.5mm, 12/14
• 10885862658340: BIOLOX®delta Femoral Head: 28mm O.D., +0mm, 12/14