Sagittae

Basic Information

• Brand Name: Sagittae
• Primary DI: 00819837020583
• Version / Model: 902-030-00
• Catalog Number: 902-030-00
• Company Name: SPINEEX, INC.
• Labeler DUNS: 080723590
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-22
• Public Version: 1
• Public Version Date: 2019-10-30
• Public Version Status: New
• Public Device Record Key: 022fd6b9-4525-4364-9b80-8383fa2f2d4f

Device Description

Torque Limiting Handle, 162mm 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.00 Nm, Blue

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47830	Surgical instrument handle, torque-limiting	A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819837020583	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181531	000