FDA.reportPublic FDA data

Irix-C Cervical Integrated Fusion System

Primary DI
M697T06600910
Brand
Irix-C Cervical Integrated Fusion System
Company
X-SPINE SYSTEMS, INC.
Model
T066-0091
Device description
14mm, Straight Drill
Published
2015-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBIT, DRILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697T06600910Direct MarkingHIBCC0
M697T06600911PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA 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
TypeValueUnit
Length14Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(937)847-8400orders@x-spine.com

Regulatory Flags#

DUNS number
610042587
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M697C07800240H-Graft Interspinous AllograftC078-00242021-05-19
M697C07902610Silex Sacroiliac Joint Fusion SystemC079-02612021-05-19
M697C07902620Silex Sacroiliac Joint Fusion SystemC079-02622021-05-19
M697C01000880Fortex Pedicle Screw SystemC010-00882021-04-30
M697C00300090Calix Spinal Implant SystemC003-00092016-08-30
M697C00300260Calix Spinal Implant SystemC003-00262018-01-10
M697C00300270Calix Spinal Implant SystemC003-00272018-01-10
M697C00300280Calix Spinal Implant SystemC003-00282018-01-10
M697C00300290Calix Spinal Implant SystemC003-00292018-01-10
M697C00300300Calix Spinal Implant SystemC003-00302018-01-10
M697C00300310Calix Spinal Implant SystemC003-00312018-01-10
M697C00300320Calix Spinal Implant SystemC003-00322018-01-10
M697C00300330Calix Spinal Implant SystemC003-00332018-01-10
M697C00300340Calix Spinal Implant SystemC003-00342017-05-05
M697C00300350Calix Spinal Implant SystemC003-00352017-05-05
M697C00300360Calix Spinal Implant SystemC003-00362017-05-05
M697C00300370Calix Spinal Implant SystemC003-00372017-05-05
M697C00300380Calix Spinal Implant SystemC003-00382017-05-05
M697C00300390Calix Spinal Implant SystemC003-00392017-05-05
M697C00300400Calix Spinal Implant SystemC003-00402017-05-05

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Primary DI, Brand, Company table
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09353903030218Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-06-24
00889795154507Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154514Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154521Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154606Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
08800089483433Drill bitJeil Medical CorporationHTW2026-06-10
08800089483457Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTW2026-06-10
04052536176700neon3Ulrich GmbH & Co. KGHTW2026-06-08
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