Home GUDID B330PC02700
Osseoflex PC Pre-Curved Bone Tamp 10ga
Primary DI B330PC02700
Brand Osseoflex PC Pre-Curved Bone Tamp 10ga
Company OSSEON LLC
Model PC-0270
Device description The Osseoflex PC Pre-Curved Bone Tamp is a mechanical device used to disrupt cancellous bone by channeling through the bone creating a void within a vertebral body. The Osseoflex PC Pre-Curved Bone Tamp can be utilized for multiple level vertebral body access. The channel can be used to introduce an appropriately sized Osseon inflatable bone tamp.
Published 2017-04-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name HXG Tamp
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HXG Tamp Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B330PC02700 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone access channel kit A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Needle Gauge 10 Gauge
Regulatory Flags# DUNS number 079316474 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B330OF00050 Osseoflex SB Steerable Balloon (8ga/ 4ml) OF-0005 2016-09-23 B330OF02220 Osseoflex SB Steerable Balloon (10ga/2ml) OF-0222 2016-09-09 B330OF02240 Osseoflex SB Steerable Balloon ( 10 ga/ 4ml) OF-0224 2016-09-23 B330OF03480 Osseoflex CD-H OF-0348 2017-03-31 B330OF82220 Osseoflex SB Steerable Balloon (8ga/2ml) OF-8222 2016-09-23 B330OT02220 Osseoflex SB Straight Balloon (10ga/2ml) OT-0222 2016-09-23 B330OT02240 Osseoflex SB Straight Balloon (10ga/4ml) OT-0224 2016-09-23
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