SonicAnchor

Basic Information

• Brand Name: SonicAnchor
• Primary DI: 07613327096170
• Version / Model: 1910-1271S
• Catalog Number: 1910-1271S
• Company Name: Stryker Trauma GmbH
• Labeler DUNS: 330211587
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 5
• Public Version Date: 2019-03-21
• Public Version Status: Update
• Public Device Record Key: 558e6f42-b047-472d-9903-2fae82ab9e84

Device Description

SONICANCHOR KIT

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTY	PIN, FIXATION, SMOOTH	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45061	Tendon/ligament bone anchor, bioabsorbable	A bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327096170	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Diameter: 2.5 Millimeter
Length	10.0	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -5 – 25 Degrees Celsius