← Back to catalogue

Odyssey K3

FDA UDI

Class I (US FDA UDI)

by College Park Industries, Inc.

Identity

Trade Name
Odyssey K3 FDA UDI
Generic Name
Hydraulic/pneumatic external ankle-foot prosthesis FDA UDI
Device Name
Odyssey K3 Foot, Endo IP, 24cm, Category 2 FDA UDI
Model / Reference
ODK3 EN 24 D2 FDA UDI
Description
Odyssey K3 Foot, Endo IP, 24cm, Category 2 FDA UDI

Identifiers

Primary DI / UDI-DI
00195411041329 FDA UDI
FDA Product Code
ISH FDA UDI
GMDN Term
Hydraulic/pneumatic external ankle-foot prosthesis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3420 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

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hydraulic/pneumatic external ankle-foot prosthesis

Odyssey K3 by College Park Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hydraulic/pneumatic external ankle-foot prosthesis.

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
College Park Industries, Inc.

Sources (1)

  • FDA UDI fb7704d5-235e-440c-be05-25c27b205243 34 fields · synced May 30, 2026