n/a 863-8071

by Ortho Development Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

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	Number00822409106820 UDI-DI	Date24 Dec 2021Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Knee tibia prosthesis trial, reusable
Model / Reference: 863-8071

Primary DI / UDI-DI: 00822409106820
510(k) Number: K211471
FDA Product Code: HSX
GMDN Term: Knee tibia prosthesis trial, reusable

Device Class: Class II
Regulation Number: 888.3520
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Size: Height — 7 Millimeter

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N/A 233-0140

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N/A 233-0142

Class I
N/A 233-0141

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