FDA.reportPublic FDA data

Odyssey K2

Primary DI
00195411087723
Brand
Odyssey K2
Company
COLLEGE PARK INDUSTRIES, INC.
Model
OK2 LBEN 23 D2
Device description
Odyssey K2 Foot, Left, Brown, Endo IP, 23cm, Category 2
Published
2023-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISHComponent, External, Limb, Ankle/Foot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISHComponent, External, Limb, Ankle/FootPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195411087723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195411087723001954110877231954110877230195411087723

GMDN Terms#

Term, Definition table
TermDefinition
Hydraulic/pneumatic external ankle-foot prosthesisA device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion motion control is based on hydraulics and/or pneumatics (e.g., using fixed fluid orifices, or needle or servo valves). It responds to changes in motion by providing variable damping through progressive adjustments [i.e. over several steps] in motion resistance. It may have various designs and functional features (e.g., integrated carbon fibre blade, split/sandal toe, adjustable heel height) for support during a variety of activities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-728-7950orders@college-park.com

Regulatory Flags#

DUNS number
623191137
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195411492992Terrain VSTN VS LBEN 21 D12026-08-27
00195411493005Terrain VSTN VS LBEN 21 D22026-08-27
00195411493012Terrain VSTN VS LBEN 21 D32026-08-27
00195411493029Terrain VSTN VS LBEN 21 D42026-08-27
00195411493036Terrain VSTN VS LBEN 21 D52026-08-27
00195411493043Terrain VSTN VS LBEN 21 D62026-08-27
00195411493050Terrain VSTN VS LBEN 21 D72026-08-27
00195411493067Terrain VSTN VS LBEN 21 D82026-08-27
00195411493074Terrain VSTN VS LBEN 22 D12026-08-27
00195411493081Terrain VSTN VS LBEN 22 D22026-08-27
00195411493098Terrain VSTN VS LBEN 22 D32026-08-27
00195411493104Terrain VSTN VS LBEN 22 D42026-08-27
00195411493111Terrain VSTN VS LBEN 22 D52026-08-27
00195411493128Terrain VSTN VS LBEN 22 D62026-08-27
00195411493135Terrain VSTN VS LBEN 22 D72026-08-27
00195411493142Terrain VSTN VS LBEN 22 D82026-08-27
00195411493159Terrain VSTN VS LBEN 23 D12026-08-27
00195411493166Terrain VSTN VS LBEN 23 D22026-08-27
00195411493173Terrain VSTN VS LBEN 23 D32026-08-27
00195411493180Terrain VSTN VS LBEN 23 D42026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195411492992Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493005Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493012Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493029Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493036Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493043Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493050Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493067Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493074Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493081Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493098Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493104Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493111Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493128Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493135Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493142Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493159Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493166Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493173Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493180Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493197Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493203Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493210Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493227Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493234Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493241Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493258Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493265Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493272Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493289Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27