BIOSORB P822367222

GUDID 03760154002059

Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity

S.B.M

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: 03760154002059
• NIH Device Record Key: d475e3ad-7934-4aa9-9fd1-9e4f018efa93
• Commercial Distribution Discontinuation: 2020-01-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BIOSORB
• Version Model Number: OTIS 50
• Catalog Number: P822367222
• Company DUNS: 772462123
• Company Name: S.B.M
• 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: true
• 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: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us

Device Dimensions

• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760154002059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071155

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: 4
• Public Version Date: 2020-01-10
• Device Publish Date: 2015-10-13

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