BioSphere Flex, Large

GUDID M958BSF251000

BioSphere Flex, Large

SYNERGY BIOMEDICAL, LLC

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: M958BSF251000
• NIH Device Record Key: 29b618e5-ad05-4de4-b12a-f3a42f84c1e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioSphere Flex, Large
• Version Model Number: BSF-25100
• Company DUNS: 078270195
• Company Name: SYNERGY BIOMEDICAL, LLC
• 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: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com
• Phone: 484-902-8141
• Email: customerservice@synergybiomedical.com

Device Dimensions

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Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M958BSF251000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173424

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-09
• Device Publish Date: 2021-06-01

Devices Manufactured by SYNERGY BIOMEDICAL, LLC

• M958BMS250KT0 - BioSphere MIS Kit: 2024-12-17
• M958BMS250RC0 - BioSphere MIS Replacement Cannula: 2024-12-17
• M958BSF000300 - BioSphere Flex SP Extremities, Small: 2021-06-09 BioSphere Flex SP Extremities, Small
• M958BSF000400 - BioSphere Flex SP Extremities, Medium: 2021-06-09 BioSphere Flex SP Extremities, Medium
• M958BSF250500 - BioSphere Flex, Medium: 2021-06-09 BioSphere Flex, Medium
• M958BSF251000 - BioSphere Flex, Large: 2021-06-09BioSphere Flex, Large
• M958BSF251000 - BioSphere Flex, Large: 2021-06-09 BioSphere Flex, Large
• M958BSF00075 - BioSphere Flex SP: 2020-02-10