ActivaNail™

FDA UDI

Class II (US FDA UDI)

by Bioretec Oy

Identity

Trade Name: ActivaNail™ FDA UDI
Generic Name: Orthopaedic bone pin, bioabsorbable FDA UDI
Device Name: ActivaNail™ Conical 1.5 mm x 25 mm FDA UDI
Model / Reference: B-ANCO-1525 FDA UDI
Description: ActivaNail™ Conical 1.5 mm x 25 mm FDA UDI

Identifiers

Catalog Number: B-ANCO-1525 FDA UDI
Primary DI / UDI-DI: E302BANCO15259 FDA UDI
510(k) Number: K080879 FDA UDI
FDA Product Code: HTY FDA UDI
GMDN Term: Orthopaedic bone pin, bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Width — 1.5 Millimeter FDA UDI
Length — 25 Millimeter FDA UDI

Category: Orthopaedic bone pin, bioabsorbable

ActivaNail Conical Orthopedic Bone Pin for fixation of bone fractures or grafts, or osteotomies or arthrodeses in the presence of additional immobilization. Chemically degraded and typically absorbed by natural body processes.

Similar devices

Also classified as Orthopaedic bone pin, bioabsorbable.

Self-Reinforced Technology — Conmed Corporation · Class II
OSSIOfiber™ Hammertoe Fixation Implant — OSSIO LTD · Class II
OSSIOfiber® Trimmable Fixation Nail System, Cannulated — OSSIO LTD · Class I
Self-Reinforced Technology — Conmed Corporation · Class II
AESCULAP — AESCULAP, INC. · Class II
SmartNail Self-Reinforced Technology — Conmed Corporation · Class II
OSSIOfiber® Trimmable Fixation Nail System — OSSIO LTD · Class I
REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

K080879 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bioretec Oy

Sources (1)

FDA UDI 44f1a763-e483-4704-b810-6381550aef00 38 fields · synced Jul 20, 2026