Device
Connector Bar 400mm
Manufacturer
Xtant Medical Holdings, Inc.
Model: 02-CONNECT-BAR-400 Catalog: 02-CONNECT-BAR-400 DI: 00840311250448 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-04-30 Current Version: 2026-05-08
Description
Connector Bar 400mm
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: ffb60e1d-ddfe-49e2-a99a-07d382f6399e
Distribution Status: In Commercial Distribution
DUNS Number: 081224143
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Item #1 - Device ID: 00846468074975
Item #1 - Device ID Type: Previous
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00840311250448
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 47870
Name: Orthopaedic fixation implant alignment tool
Definition:
A surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.
FDA Product Codes
LXH
Orthopedic manual surgical instrument