FDA.reportPublic FDA data

Calix Spinal Implant System

Primary DI
M697X00300320
Brand
Calix Spinal Implant System
Company
X-SPINE SYSTEMS, INC.
Model
X003-0032
Device description
Tamp Assembly
Published
2015-11-13
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
HXGTAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697X00300320Direct MarkingHIBCC0
M697X00300321PrimaryHIBCC0

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.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B8035506760ORTHOMEDORTHO-MED, INC.HXG2026-06-22
00199150076178Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXG2026-06-05
08800322752098AnyPlus®GS Medical Co., Ltd.HXG2026-01-28
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAHXG2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAHXG2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAHXG2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAHXG2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAHXG2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAHXG2025-12-17
08800038029323SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039414SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039421SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039438SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039445SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039452SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039469SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039476SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
00841732142206GENERIC Surgical InstrumentsCTL Medical CorporationHXG2025-03-31
00841732166950GENERIC Surgical InstrumentsCTL Medical CorporationHXG2024-11-01
08800038058262SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058279SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058286SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25