Home GUDID 00840916156947 ZEUS-O
Primary DI 00840916156947
Brand ZEUS-O
Company SPINAL ELEMENTS
Model 10500
Device description ZEUS®-O CURVED ROD INSERTER ASSEMBLY
Published 2020-05-11
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840916156947 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840916156947 00840916156947 840916156947 0840916156947
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 004022104 Device count 1 DM exempt true Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00888867550292 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550308 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550315 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550322 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550339 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550346 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550353 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550360 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550377 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550384 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552692 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552708 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552715 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552722 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552739 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552746 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552753 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552760 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867574564 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867574571 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867574588 Arthrex® ARTHREX, INC. LXH 2026-09-18 04054896000831 Control Gauges Silony Medical GmbH LXH 2026-09-18 04054896000855 Implant Modifier Silony Medical GmbH LXH 2026-09-18 04054896000862 Implant Modifier Silony Medical GmbH LXH 2026-09-18 04054896000879 Implant Modifier Silony Medical GmbH LXH 2026-09-18 04054896000886 Forceps and Clamps Silony Medical GmbH LXH 2026-09-18 04054896000893 (Re-) Positioning Tools Silony Medical GmbH LXH 2026-09-18 04054896000909 (Re-) Positioning Tools Silony Medical GmbH LXH 2026-09-18 04054896000916 (Re-) Positioning Tools Silony Medical GmbH LXH 2026-09-18 04054896000923 Adapter Silony Medical GmbH LXH 2026-09-18