FDA.reportPublic FDA data

VAN GOGH Anterior Cervical Plate System

Primary DI
00841732144200
Brand
VAN GOGH Anterior Cervical Plate System
Company
CTL Medical Corporation
Model
011.0834
Device description
VAN GOGH Screw, FA, Self-Tapping, T10, 4.0 x L14mm
Published
2023-12-28
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
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121078000VAN GOGH ANTERIOR CERVICAL PLATE SYSTEMAccel Spine2012-09-13KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732144200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732144200008417321442008417321442000841732144200

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
+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
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
00841732154766VALEO C+CSC with Lumen Interbody Fusion Device11.209.11082023-09-19
00841732154773VALEO C+CSC with Lumen Interbody Fusion Device11.209.11092023-09-19
00841732154780VALEO C+CSC with Lumen Interbody Fusion Device11.209.11102023-09-19
00841732154797VALEO C+CSC with Lumen Interbody Fusion Device11.209.11112023-09-19
00841732154803VALEO C+CSC with Lumen Interbody Fusion Device11.209.17052023-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-30
00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425399RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425405RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425412RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425429RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425436RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425443RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425450RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425467RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425474RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28