FDA.reportPublic FDA data

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation

Primary DI
00841732169265
Brand
MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation
Company
CTL Medical Corporation
Model
113.7514
Device description
2 Hole Plate Lateral Grabber, M
Published
2026-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182151000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732169265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732169265008417321692658417321692650841732169265

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(214)545-5820schedule@ctlamedica.com

Regulatory Flags#

DUNS number
080138504
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00841732169258MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation113.75132026-11-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169258MONET Anterior Cervical Interbody Fusion Cage System with Supplementary FixationCTL Medical CorporationOVE2026-11-02
B678522207S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522208S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522209S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522210S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522211S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522212S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522213S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522214S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522215S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522216S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B06234500010Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500020Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500030Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500040Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500050Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500052Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500053Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500054Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500061Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500062Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500063Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500064Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500070Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500071Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500080Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500081Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500090Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500100Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500110Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29