PIT'STOP®

GUDID 03760225713358

IN2BONES

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Primary Device ID	03760225713358
NIH Device Record Key	a2e9f1bc-5819-4c18-90ef-4368ee81c2f1
Commercial Distribution Status	In Commercial Distribution
Brand Name	PIT'STOP®
Version Model Number	M20 SP012
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

Device Dimensions

Length	14.4 Millimeter
Width	12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760225713358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170688

FDA Product Code

HWC	Screw, Fixation, Bone

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2024-02-19
Device Publish Date	2018-04-20