Prosthesis Trial
Prosthesis Trial (IZ04352) is a Class I device made by Adler Ortho SpA, listed in FDA GUDID since 4 Aug 2025 (UDI-DI 08056269046695), registry data as of 21 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08056269046695 | Date4 Aug 2025 | StatusListed |
Official records
- AccessGUDID record 08056269046695
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Hip revision prosthesis trial
- Model / Ref / Catalog
- Prosthesis Trial, IZ04352
- Primary DI / UDI-DI
- 08056269046695
- FDA product code
- LXH
- GMDN term
- Hip revision prosthesis trial
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices
Other devices filed under FDA product code LXH (Orthopedic Manual Surgical Instrument).
- INSTRUMENT 6496-3-101 by Howmedica Osteonics Corp.
- Knee Instruments 02.18.10.1079 by Medacta International SA
- ACUMED 80-4164 by ACUMED LLC
- Sayan 1042.37.003 by SAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETI
- APEX Knee System KS-40512 by OMNIlife science, Inc.
- PRO 703967 by Stryker GmbH
- NAPA Access System 8030-90204 by VB Spine LLC
- Spine Instruments 03.22.10.1055 by Medacta International SA
- Screwdriver Shaft 4812-045-03 00-4812-045-03 by Zimmer, Inc.
- Tornier Perform MWJ118 by TORNIER, INC.