← Back to catalogue

DuaFit®

FDA UDI

Class II (US FDA UDI)

by In2bones

Identity

Trade Name
DuaFit® FDA UDI
Generic Name
Phalangeal joint arthrodesis implant FDA UDI
Device Name
DUAFIT PIP 17° PEEK STERILE SIZE 1 FDA UDI
Model / Reference
A60 SP171 FDA UDI
Description
DUAFIT PIP 17° PEEK STERILE SIZE 1 FDA UDI

Identifiers

Catalog Number
A60 SP171 FDA UDI
Primary DI / UDI-DI
03760225710449 FDA UDI
510(k) Number
K132912 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Phalangeal joint arthrodesis implant 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 11 Millimeter FDA UDI
Angle — 17 degree FDA UDI

Category: Phalangeal joint arthrodesis implant

DuaFit® by In2bones — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Phalangeal joint arthrodesis implant.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
In2bones

Sources (1)

  • FDA UDI 4316d838-8af9-4632-a381-9f8cbcd4901f 37 fields · synced May 31, 2026