N/A 613-4002

by Ortho Development Corp. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00822409116676 UDI-DI	Date1 Apr 2024Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Generic Name: Femoral stem prosthesis trial
Model / Reference: 613-4002

Primary DI / UDI-DI: 00822409116676
FDA Product Code: MEH
GMDN Term: Femoral stem prosthesis trial

Device Class: Class II
Regulation Number: 888.3353
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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N/A 233-0142

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Class I

See all devices from Ortho Development Corp. →

Properties

Lot / Batch Number
Manufacturing Date

Other properties (12)

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
Premarket Exempt: No
Serial Number: No
Expiration Date: No