FDA.reportPublic FDA data

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation

Primary DI
00841732159617
Brand
MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation
Company
CTL Medical Corporation
Model
L.113.1207
Device description
"MONET Plate, Medium, 2 Holes, H7mm ""No Spikes"""
Published
2023-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172788000
K182151000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172788000MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation2018-06-25ODP
K182151000MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation PlateCtl Medical Corporation2018-10-11OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732159617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732159617008417321596178417321596170841732159617

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2145455820schedule@ctlamedica.com

Regulatory Flags#

DUNS number
080138504
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841732168091MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87002026-08-14
00841732168107MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87042026-08-14
00841732168114MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87012026-08-14
00841732168121MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87022026-08-14
00841732168138MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87032026-08-14
00841732168527TAURUS Pedicle Screw System059.80132026-07-28
00841732169272PICASSO MIS Spinal System016.31602026-07-24
00841732169289PICASSO MIS Spinal System016.31702026-07-24
00841732169296PICASSO MIS Spinal System016.31802026-07-24
00841732169302PICASSO MIS Spinal System016.31902026-07-24
00841732169319PICASSO MIS Spinal System016.32002026-07-24
00841732163447VALEO C Spacer System91.002.40012023-09-30
00841732163454VALEO C Spacer System91.002.40022023-09-30
00841732163461VALEO C Spacer System91.002.40032023-09-30
00841732128231VALEO VBR91.009.56512023-09-27
00841732128248VALEO VBR91.009.56522023-09-27
00841732145511VALEO C+CSC with Lumen Interbody Fusion Device11.209.17072023-09-19
00841732145528VALEO C+CSC with Lumen Interbody Fusion Device11.209.17082023-09-19
00841732145535VALEO C+CSC with Lumen Interbody Fusion Device11.209.17092023-09-19
00841732145542VALEO C+CSC with Lumen Interbody Fusion Device11.209.17102023-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800322776391QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776407QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776414QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776421QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776438QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776445QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776452QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776469QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776476QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776483QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776490QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776506QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776513QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776520QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776537QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776544QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776551QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776568QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776575QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776582QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776599QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776605QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776612QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776629QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776636QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776643QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776650QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776667QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776674QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776681QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18