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Phalinx

FDA UDI

Class II (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name
PHALINX FDA UDI
Generic Name
Phalangeal joint arthrodesis implant FDA UDI
Model / Reference
45301011 FDA UDI

Identifiers

Primary DI / UDI-DI
00840420166067 FDA UDI
510(k) Number
K142585 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

No

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

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Phalangeal joint arthrodesis implant

A reliable and effective solution for managing arthritis or deformities in the finger, toe, or other joints through arthrodesis, a surgical procedure that fuses two or more bones together. The PHALINX device is designed to be inserted within a phalangeal joint using a small, non-bioabsorbable implant made of metal.

Similar devices

Also classified as Phalangeal joint arthrodesis implant.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wright Medical Technology, Inc.

Sources (1)

  • FDA UDI 0e49b5ef-edc6-4e58-81c8-6f7fd9160744 35 fields · synced Jul 9, 2026