Home GUDID B07330TNS32120 Navagio
Primary DI B07330TNS32120
Brand Navagio
Company Kalitec Direct LLC
Model 30-TNS-3212
Catalog number 30-TNS-3212
Device description Lumbar Cage, 32x12mm 0-Degree STR
Published 2022-05-31
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B07330TNS32120 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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 041956211 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B073DRK0100300 Cosmolock DR-K01-0030 DR-K01-0030 2021-03-16 B073K0730000 Matira 07-K07-3000 07-K07-3000 2020-01-03 B07307CPR01181 Matira Anterior Cervical Plate System 07-CPR-0118 07-CPR-0118 2017-10-31 B07307CPR01191 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0119 07-CPR-0119 2017-10-31 B07307CPR01201 MATIRA ANTERIOR CERVICAL PLATE SYSTEM 07-CPR-0120 07-CPR-0120 2017-10-31 B07307CPR01211 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0121 01-CPR-0121 2017-10-31 B07307CPR01221 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0122 07-CPR-0122 2017-10-31 B07307CPR01241 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0124 07-CPR-0124 2017-10-31 B07307CPR01261 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0126 07-CPR-0126 2017-10-31 B07307CPR01281 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0128 07-CPR-0128 2017-10-31 B07307CPR01301 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0130 07-CPR-0130 2017-10-31 B07307CPR01321 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0132 07-CPR-0132 2017-10-31 B07307CPR01341 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0134 07-CPR-0134 2017-10-31 B07307CPR02321 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0232 07-CPR-0232 2017-10-31 B07307CPR02341 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0234 07-CPR-0234 2017-10-31 B07307CPR02361 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0236 07-CPR-0236 2017-10-31 B07307CPR02381 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0238 07-CPR-0238 2017-10-31 B07307CPR02401 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0240 07-CPR-0240 2017-10-31 B07307CPR02421 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0242 07-CPR-0242 2017-10-31 B07307CPR02441 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0244 07-CPR-0244 2017-10-31
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