ActivaScrew™

Basic Information

• Brand Name: ActivaScrew™
• Primary DI: E302BALC35209
• Version / Model: B-ALC-3520
• Catalog Number: B-ALC-3520
• Company Name: Bioretec Oy
• Labeler DUNS: 368715301
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-21
• Public Version: 5
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: 418e99af-e4a6-48ad-823b-b5492976f6a3

Device Description

ActivaScrew™ Cannulated LAG 3.5x20 mm, thread 8 mm

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45039	Bioabsorbable orthopaedic bone screw	A small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E302BALC35209	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K081392	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Thread length 8 Millimeter
Length	20	Millimeter
Width	3.5	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit