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Endoskeletal Components

FDA UDI

Class I (US FDA UDI)

by College Park Industries, Inc.

Identity

Trade Name
Endoskeletal Components FDA UDI
Generic Name
External lower-limb prosthesis structural/alignment component FDA UDI
Device Name
30mm Transtibial Kit w/ Rotatable Pyramid Adapter w/ Pin-Lock Hole, Ti FDA UDI
Model / Reference
TI TTK PHR FDA UDI
Description
30mm Transtibial Kit w/ Rotatable Pyramid Adapter w/ Pin-Lock Hole, Ti FDA UDI

Identifiers

Primary DI / UDI-DI
00195411192304 FDA UDI
FDA Product Code
IQO FDA UDI
GMDN Term
External lower-limb prosthesis structural/alignment component FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3025 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: External lower-limb prosthesis structural/alignment component

This comprehensive medical device provides an external lower-limb prosthesis structural/alignment component designed to enable adjustment of the orientation of the prosthesis components relative to each other and to the patient.

Similar devices

Also classified as External lower-limb prosthesis structural/alignment component.

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 86fcf11e-f2f4-453d-905d-4d45c3dcb2cc 34 fields · synced Jun 30, 2026