ALTAPORE 1508047

GUDID 00085412678146

Bioactive and Osteoconductive - Silicate Substituted Calcium Phosphate bone void filler

Apatech Ltd

Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 00085412678146
• NIH Device Record Key: 195709d1-eabf-4991-81b9-acea4aae61be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALTAPORE
• Version Model Number: 1508047
• Catalog Number: 1508047
• Company DUNS: 221517829
• Company Name: Apatech 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.co
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.com
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.com
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.com
• Phone: +1(888)229-0001
• Email: cfs_customer_service@baxter.com

Device Dimensions

• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter
• Total Volume: 7.5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412678146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201464

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-01-05
• Device Publish Date: 2020-11-05

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• 05413760478968: Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate
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• 00085412654379: Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate
• 00085412654362: Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate
• 00085412678146: Bioactive and Osteoconductive - Silicate Substituted Calcium Phosphate bone void filler
• 00085412630731: Bioactive and Osteoconductive - Silicate Substituted Calcium Phosphate bone void filler