Home GUDID B678823125L0 Tranquil-L™
Primary DI B678823125L0
Brand Tranquil-L™
Company NEXUS SPINE, L.L.C.
Model 823125L
Device description Large Hinged Cervical Paddle Distractor
Published 2022-02-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1 MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B678823125L Direct Marking HIBCC 0 B678823125L0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Metallic spinal interbody fusion cage A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 028137605 Device count 1 Premarket exempt true Lot or batch true 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 00840286860093 Tahoe Unicompartmental Knee System Shalby Advanced Technologies, Inc. LXH 2026-07-09 00840286860109 Tahoe Unicompartmental Knee System Shalby Advanced Technologies, Inc. LXH 2026-07-09 00840286860116 Tahoe Unicompartmental Knee System Shalby Advanced Technologies, Inc. LXH 2026-07-09 10705034647463 N/A Medos International Sàrl LXH 2026-07-09 B382SD49400B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49401B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49402B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49403B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49404B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49405B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49406B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49407B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49408B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49409B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49410B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49411B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49412B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49413B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49414B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49415B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49416B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49417B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49418B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49419B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49420B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500010 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500020 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500030 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500040 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500050 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09