2.7mm T10 Drive Bypass Cortical Locking Screw, 14mm

Basic Information

• Brand Name: 2.7mm T10 Drive Bypass Cortical Locking Screw, 14mm
• Primary DI: 00816101017751
• Version / Model: NA
• Catalog Number: TO-27-T10-BLS-14
• Company Name: TOBY ORTHOPAEDICS
• Labeler DUNS: 024163331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-17
• Public Version: 4
• Public Version Date: 2025-02-06
• Public Version Status: Update
• Public Device Record Key: 6740cdd4-969a-4d51-a416-c815e3c86da0

Device Description

The titanium alloy bypass locking screws (torx T-10 head) are designed to affix the plate to the bone using a similar design as the cortical locking screw, except that the screw head includes scallops that allow a second locking screw to be installed in the adjacent hole. The bypass locking screws are 2.7mm in diameter and are available in multiple lengths ranging from 10mm to 34mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66947	Orthopaedic bone screw (non-sliding)	A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816101017751	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K081608	000