TruStep TS LTALX 27W D8

by College Park Industries, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00195411099894 UDI-DI	Date16 Oct 2023Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: TruStep
Generic Name: Mechanical-resistance external ankle-foot prosthesis
Model / Reference: TS LTALX 27W D8

Primary DI / UDI-DI: 00195411099894
FDA Product Code: ISH
GMDN Term: Mechanical-resistance external ankle-foot prosthesis

Device Class: Class I
Regulation Number: 890.3420
GUDID distribution status: In Commercial Distribution

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Properties

Premarket Exempt
Serial Number
Manufacturing Date

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Lot / Batch Number: No
Expiration Date: No