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EpiFIX

FDA UDI

Class II (US FDA UDI)

by Wishbone Medical Inc.

Identity

Trade Name
EpiFIX FDA UDI
Generic Name
Growth-correction orthopaedic fixation plate kit FDA UDI
Device Name
Express Kit, Curved 2-Hole X 22mm EpiFIX Plate, Instruments and Screws, SS FDA UDI
Model / Reference
XK-EFC0222S FDA UDI
Description
Express Kit, Curved 2-Hole X 22mm EpiFIX Plate, Instruments and Screws, SS FDA UDI

Identifiers

Catalog Number
XK-EFC0222S FDA UDI
Primary DI / UDI-DI
B562XKEFC0222S0 FDA UDI
510(k) Number
K182704 FDA UDI
FDA Product Code
OBT FDA UDI
GMDN Term
Growth-correction orthopaedic fixation plate kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Yes

FDA UDI

EpiFIX by Wishbone Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K182704 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wishbone Medical Inc.

Sources (1)

  • FDA UDI ff5bcef7-fe2a-43e9-ac80-17d3b0df20ea 36 fields · synced Jun 8, 2026