FDA.reportPublic FDA data

MATISSE Anterior Cervical Interbody Fusion Cage System

Primary DI
00841732106222
Brand
MATISSE Anterior Cervical Interbody Fusion Cage System
Company
CTL Medical Corporation
Model
013.8401
Device description
MATISSE™ ACIF Cage Implant Tray, W20xL16
Published
2024-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121569000MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEMAccel Spine2012-07-27ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732106222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732106222008417321062228417321062220841732106222

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(214)545-5820complaints@ctlmed.com
+1(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
00190376733470CONTOUR3DALPHATEC SPINE, INC.FSM2026-09-25
00889795135278Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135285Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135292Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135308Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135315Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135322Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135339Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
10889950159221Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-09-24
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.ODP2026-09-22
07613327506570CASCADIA Interbody SystemVB Spine LLCFSM2024-04-25
07613327506624CASCADIA Interbody SystemVB Spine LLCFSM2024-04-25
B7685720100Buxton BioMedicalBUXTON BIOMEDICAL, INC.FSM2024-04-17
B7685451910Buxton BiomedicalBUXTON BIOMEDICAL, INC.FSM2023-12-08
B7682486110Buxton BioMedicalBUXTON BIOMEDICAL, INC.FSM2023-09-15
B7682485110Buxton BioMedicalBUXTON BIOMEDICAL, INC.FSM2023-02-14
B7685710230Buxton BioMedicalBUXTON BIOMEDICAL, INC.FSM2023-02-02
B7685734110Buxton BioMedicalBUXTON BIOMEDICAL, INC.FSM2023-02-02
B7685735110Buxton BioMedicalBUXTON BIOMEDICAL, INC.FSM2023-02-02
B7685744110Buxton BioMedicalBUXTON BIOMEDICAL, INC.FSM2023-02-02
B7682459050Buxton BioMedicalBUXTON BIOMEDICAL, INC.FSM2023-01-10
B7682459070Buxton BioMedicalBUXTON BIOMEDICAL, INC.FSM2023-01-10
07613327506549Monterey ALStryker CorporationFSM2022-03-21
07613327506556Monterey ALStryker CorporationFSM2022-03-21
07613327506563Monterey ALStryker CorporationFSM2022-03-21
07613327506587Monterey ALStryker CorporationFSM2022-03-21
07613327506600Monterey ALStryker CorporationFSM2022-03-21