Home GUDID M697X03412311 Calix Spinal Implant System
Primary DI M697X03412311
Brand Calix Spinal Implant System
Company Xtant Medical Holdings, Inc.
Model X034-1231
Device description 36mm x 24mm x 10mm ALIF BOX BROACH
Published 2015-11-13
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 HTQ BROACH
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTQ Broach Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697X03412310 Direct Marking HIBCC 0 M697X03412311 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.
Device Sizes# Type, Value, Unit table Type Value Unit Height 10 Millimeter Length 36 Millimeter Width 24 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081224143 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 10603295079965 AML EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080176 EXCEL TRI-LOCK DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080183 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080190 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080206 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080213 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080220 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080237 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080244 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080251 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080268 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080275 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080282 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080299 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080305 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080312 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080329 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080336 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080343 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080350 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080367 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080374 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080381 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295082057 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082064 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082071 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082088 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082095 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082101 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082118 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24
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