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Solar

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name
SOLAR FDA UDI
Generic Name
Elbow radius prosthesis FDA UDI
Device Name
Radial Head Prosthesis FDA UDI
Model / Reference
6948-0-609 FDA UDI
Description
Radial Head Prosthesis FDA UDI

Identifiers

Catalog Number
6948-0-609 FDA UDI
Primary DI / UDI-DI
07613327135985 FDA UDI
510(k) Number
K001385 FDA UDI
FDA Product Code
KWI FDA UDI
GMDN Term
Elbow radius prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3170 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

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

No

FDA UDI

Category: Elbow radius prosthesis

Solar by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Elbow radius prosthesis.

Cleared under the same submission

K001385 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Howmedica Osteonics Corp.

Sources (1)

  • FDA UDI d4fce9e5-90fe-42c7-b64c-3254d90a3ef2 36 fields · synced Jun 8, 2026