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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, Left, Tan, Endo IP, 28cm, Category 3 FDA UDI
Model / Reference
ODK3 LTEN 28 D3 FDA UDI
Description
Odyssey K3 Foot, Left, Tan, Endo IP, 28cm, Category 3 FDA UDI

Identifiers

Primary DI / UDI-DI
00195411039036 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

The Odyssey K3 Foot, Left, Tan, Endo IP, 28cm, Category 3 is a hydraulic/pneumatic external ankle-foot prosthesis designed for individuals with severe lower limb amputations. It provides functional replacement of the absent foot and/or ankle, using variable damping through progressive adjustments to respond to changes in motion.

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
College Park Industries, Inc.

Sources (1)

  • FDA UDI 4031c8f3-7c5b-4493-b730-1d966c047fae 34 fields · synced Jun 27, 2026