BIOSORB P822365234

GUDID 03760154001526

Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity

S.B.M

Synthetic bone graft

• Primary Device ID: 03760154001526
• NIH Device Record Key: cf065c90-57af-467a-98b3-040ff499190e
• Commercial Distribution Discontinuation: 2020-01-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BIOSORB
• Version Model Number: OTIS
• Catalog Number: P822365234
• 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: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760154001526 [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

On-Brand Devices [BIOSORB]

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• 03760154004824: Absorbable calcium salt bone void filler
• 03760154004688: Absorbable calcium salt bone void filler
• 03760154004671: Absorbable calcium salt bone void filler
• 03760154004640: Absorbable calcium salt bone void filler
• 03760154004633: Absorbable calcium salt bone void filler
• 03760154004282: Absorbable calcium salt bone void filler
• 03760154004275: Absorbable calcium salt bone void filler
• 03760154004237: Absorbable calcium salt bone void filler
• 03760154004220: Absorbable calcium salt bone void filler
• 03760154002141: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity
• 03760154002134: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity
• 03760154002110: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity
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• 03760154002097: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity
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• 03760154002073: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity
• 03760154002066: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity
• 03760154002059: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity
• 03760154001540: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity
• 03760154001533: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity
• 03760154001526: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity
• 03760154001519: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity
• 03760154001502: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity
• 03760154001489: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity
• 03760154001472: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity
• 03760154000697: Absorbable calcium salt bone void filler
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• 03760154000390: Absorbable calcium salt bone void filler
• 03760154000376: Absorbable calcium salt bone void filler
• 03760154000352: Absorbable calcium salt bone void filler
• 03760154000321: Absorbable calcium salt bone void filler
• 03760154000307: Absorbable calcium salt bone void filler
• 03760154000291: Absorbable calcium salt bone void filler
• 03760154000277: Absorbable calcium salt bone void filler
• 03760154000253: Absorbable calcium salt bone void filler
• 03760154000246: Absorbable calcium salt bone void filler
• 03760154000215: Absorbable calcium salt bone void filler
• 03760154000208: Absorbable calcium salt bone void filler
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• 03760154000161: Absorbable calcium salt bone void filler
• 03760154000154: Absorbable calcium salt bone void filler
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