FDA.reportPublic FDA data

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation

Primary DI
00841732160392
Brand
MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation
Company
CTL Medical Corporation
Model
113.0222
Device description
MONET™ Screw, VA, Self-Drilling, 4.0 x L12mm, LX
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
00841732160392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732160392008417321603928417321603920841732160392

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
214-545-5820schedule@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
B0623400141205Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141206Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141207Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141208Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141209Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141210Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141211Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400141212Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161305Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161306Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161307Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161308Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161309Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161310Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161311Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400161312Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181405Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181406Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181407Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181408Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181409Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181410Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181411Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B0623400181412Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205010Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205012Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205014Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205016Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205018Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28
B06234205020Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-28