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MyHip bone model

FDA UDI

Class II (US FDA UDI)

by Medacta International

Identity

Trade Name
MyHip bone model FDA UDI
Generic Name
Orthopaedic/craniofacial implantation planning software FDA UDI
Device Name
MyHip Femoral Bone Model - Left FDA UDI
Model / Reference
5.9050 FDA UDI
Description
MyHip Femoral Bone Model - Left FDA UDI

Identifiers

Primary DI / UDI-DI
07630030855832 FDA UDI
510(k) Number
K221725 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Orthopaedic/craniofacial implantation planning software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Category: Orthopaedic/craniofacial implantation planning software

MyHip bone model by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic/craniofacial implantation planning software.

Cleared under the same submission

K221725 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medacta International

Sources (1)

  • FDA UDI 930f1f00-ee96-4b4c-a042-3070e8e10128 34 fields · synced Jun 1, 2026