Trivicta

FDA UDI

Class II (US FDA UDI)

by Ortho Development Corp.

Identity

Trade Name: Trivicta FDA UDI
Generic Name: Press-fit hip femur prosthesis, one-piece FDA UDI
Device Name: Collarless STD Size 7 FDA UDI
Model / Reference: 513-0007 FDA UDI
Description: Collarless STD Size 7 FDA UDI

Identifiers

Primary DI / UDI-DI: 00822409123469 FDA UDI
FDA Product Code: LZO FDA UDI
KWL FDA UDI
LPH FDA UDI
MEH FDA UDI
GMDN Term: Press-fit hip femur prosthesis, one-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3360 FDA UDI
888.3358 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Press-fit hip femur prosthesis, one-piece

Trivicta by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Klassic Blade Femoral Stem, Porous, Size 1 — TOTAL JOINT ORTHOPEDICS, INC. · Class II
AMIStem-H Proximal Coating — Medacta International · Class II
RECLAIMTM — DEPUY (IRELAND) · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ortho Development Corp.

Sources (1)

FDA UDI ae970b82-805c-4eae-8376-664323ad0d9c 34 fields · synced May 30, 2026