I.B.S™

GUDID 03760225716380

IN2BONES

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 03760225716380
• NIH Device Record Key: e98d3124-f550-4d3d-9c86-290a3c0b4256
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I.B.S™
• Version Model Number: S80 ST435
• Company DUNS: 263616749
• Company Name: IN2BONES
• 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: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760225716380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131920

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2022-05-18
• Device Publish Date: 2022-05-10

On-Brand Devices [I.B.S™]

• 03760225718827: G01 10013
• 03760225718810: G01 10012
• 03760225718223: G01 70031
• 03760225717462: S80 ST320
• 03760225717349: G01 70041
• 03760225717332: G01 10022
• 03760225716380: S80 ST435
• 03760225716373: S80 ST430
• 03760225716366: S80 ST425
• 03760225716359: S80 ST420
• 03760225715109: S80 ST415
• 03760225715093: S80 ST410
• 03760225715086: S80 ST405
• 03760225715079: S80 ST315
• 03760225714577: G02 00021
• 03760225714560: G02 00011
• 03760225714553: S80 ST310
• 03760225714478: G01 90011
• 03760225714461: G01 85011
• 03760225714454: G01 80011
• 03760225714447: S25 ST010
• 03760225714225: G01 95011
• 03760225714218: G01 70011
• 03760225710982: G01 10032
• 03701337609993: S80 ST335
• 03701337609986: S80 ST325
• 03701337607210: G01 95031
• 03701337607203: G01 95021
• 03701337607197: G01 90031
• 03701337607180: G01 90021
• 03701337607173: G01 85041
• 03701337607166: G01 85021
• 03701337607159: G01 80031
• 03701337607142: G01 80021
• 03701337607135: G01 70051
• 03701337607128: G01 70021
• 03701337607111: G01 10033
• 03701337606381: S25 ST011
• 03701337600723: S80 ST330