IBS™

GUDID 03760225714546

IN2BONES

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 03760225714546
• NIH Device Record Key: dd489f1c-a6ba-4324-be65-fbfa50b6a310
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IBS™
• Version Model Number: S80 ST305
• 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
• 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
• 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
• 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
• 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
• 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	03760225714546 [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: 2022-05-16
• Device Publish Date: 2022-05-06

On-Brand Devices [IBS™]

• 03701337605513: Snap-off screw titanium
• 03701337605506: Snap-off screw titanium
• 03701337605490: Snap-off screw titanium
• 03701337605483: Snap-off screw titanium
• 03701337605476: Snap-off screw titanium
• 03701337605469: Snap-off screw titanium
• 03701337605452: Snap-off screw titanium
• 03701337605339: Snap-off screw titanium
• 03701337605322: Snap-off screw titanium
• 03701337605315: Snap-off screw titanium
• 03701337605308: Snap-off screw titanium
• 03701337605292: Snap-off screw titanium
• 03701337605285: Snap-off screw titanium
• 03760225715321: S20 ST021
• 03760225715284: S20 ST013
• 03760225715277: S20 ST011
• 03760225715246: IBS™ Neutralization screw
• 03760225714935: G01 01372
• 03760225714492: G01 01362
• 03760225714485: G01 01352
• 03760225713099: G01 01181
• 03760225713037: G01 01351
• 03760225712573: G01 01381
• 03760225712559: G01 01371
• 03760225712535: G01 01361
• 03760225714546: S80 ST305
• 03760225714539: G01 00801
• 03760225714522: G01 00781
• 03760225714324: G01 01401
• 03760225714317: G01 01321
• 03760225714300: G01 01311
• 03760225714294: G01 01301
• 03760225714287: G01 01291
• 03760225714270: G01 01281
• 03760225714249: G01 00141
• 03760225713181: G01 01251
• 03760225713174: G01 01261
• 03760225713167: G01 01271
• 03760225713082: G01 00531
• 03760225713020: G01 00731
• 03760225713013: G01 00721
• 03760225712580: G01 00802
• 03760225712566: G01 00782
• 03760225712542: G01 00732
• 03760225712528: G01 00722
• 03760225710944: G01 00881
• 03760225710487: G01 01341
• 03760225716441: S65 ST305
• 03760225716328: S65 ST310
• 03760225716311: IBS™ Neutralization screw