SmartNail Self-Reinforced Technology

FDA UDI

Class II (US FDA UDI)

by Conmed Corporation

Identity

Trade Name: SmartNail Self-Reinforced Technology FDA UDI
Generic Name: Orthopaedic bone pin, bioabsorbable FDA UDI
Device Name: SmartNail Self-Reinforced Technology Ø1.5 X 16 mm FDA UDI
Model / Reference: 531516 FDA UDI
Description: SmartNail Self-Reinforced Technology Ø1.5 X 16 mm FDA UDI

Identifiers

Catalog Number: 531516 FDA UDI
Primary DI / UDI-DI: 10845854012307 FDA UDI
FDA Product Code: MAI FDA UDI
GMDN Term: Orthopaedic bone pin, bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 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

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 16 Millimeter FDA UDI
Outer Diameter — 1.5 Millimeter FDA UDI

Category: Orthopaedic bone pin, bioabsorbable

SmartNail Self-Reinforced Technology by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone pin, bioabsorbable.

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AESCULAP — AESCULAP, INC. · Class II
ActivaPin™ — Bioretec Oy · Class II
OSSIOfiber® Trimmable Fixation Nail System — OSSIO LTD · Class I
REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc. · Class II
Inion FreedomPin™ — Inion , Ltd. · Class II

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: Conmed Corporation

Sources (1)

FDA UDI 8865968d-a1ff-4843-9799-5b2de7ed9e18 37 fields · synced May 30, 2026