Orca™ XL Knotless Tendon Repair

Basic Information

• Brand Name: Orca™ XL Knotless Tendon Repair
• Primary DI: 30854629006919
• Version / Model: AB-6800
• Catalog Number: AB-6800
• Company Name: DUNAMIS MEDICAL, LLC
• Labeler DUNS: 079471560
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-31
• Public Version: 1
• Public Version Date: 2024-02-08
• Public Version Status: New
• Public Device Record Key: 2c2265da-0518-4dfe-813f-0f7ade5850d7

Device Description

Orca™ XL Knotless Tendon Repair

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	888.3040	2
HTN	Washer, Bolt Nut	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65038	Orthopaedic fixation suture button	A small, implantable device designed to retain the loop of a ligature/suture to provide additional stability and accurate fixation during orthopaedic procedures, typically internal fixation of fractures with or without additional fixation devices (e.g., bone plates, screws). It can be of various shapes (e.g., H-shaped, round, oblong), made of non-bioabsorbable metallic materials [e.g., titanium (Ti)] and is typically implanted with dedicated implantation instruments; it may be supplied with associated sutures/ligatures.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30854629006919	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K191319	000