FDA.reportPublic FDA data

RENOIR Posterior Cervical Fixation System

Primary DI
00841732162174
Brand
RENOIR Posterior Cervical Fixation System
Company
CTL Medical Corporation
Model
012.1354
Device description
Curved Rod, D4.5 x L40mm
Published
2024-01-02
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
KWPAppliance, Fixation, Spinal Interlaminal
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121136000RENOIR POSTERIOR CERVIAL FIXATION SYSTEMAccel Spine2012-08-09KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732162174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732162174008417321621748417321621740841732162174

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
00841732168268VALEO II LL Interbody Fusion System91.020.22082025-06-30
00841732168275VALEO II LL Interbody Fusion System91.020.22102025-06-30
00841732168282VALEO II LL Interbody Fusion System91.020.22142025-06-30
00841732167377VALEO II PL OL Interbody Fusion System11.113.46132025-01-23
00841732167384VALEO II PL OL Interbody Fusion System11.113.48152025-01-23
00841732167339GENERIC Surgical Instruments31-5500-0022024-12-11
00841732141186VALEO II PL OL Interbody Fusion System91.000.90092024-11-01
00841732158658Valeo II LL110-3232024-11-01
00841732158665Valeo II LL110-3242024-11-01
00841732158672Valeo II LL110-3292024-11-01
00841732165236VALEO II LL Interbody Fusion System91.020.12002024-11-01
00841732166219VALEO II PL OL Interbody Fusion System11.113.47152024-11-01
00841732166820VALEO II LL Interbody Fusion System91.020.10012024-11-01
00841732167322VALEO II LL Interbody Fusion System91.020.10992024-11-01
00841732144361VALEO II C Interbody Fusion System12.600.16102023-09-27
00841732144378VALEO II C Interbody Fusion System12.600.16052023-09-27
00841732145610VALEO II C Interbody Fusion System12.600.10052023-09-27
00841732145627VALEO II C Interbody Fusion System12.600.16062023-09-27
00841732145634VALEO II C Interbody Fusion System12.600.16082023-09-27
00841732145641VALEO II C Interbody Fusion System12.600.20052023-09-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157082031ZAVATION SCREWZavation LLCKWP2026-06-05
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00197157082109ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082116ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082123ZAVATION SCREWZavation LLCKWP2026-06-05
00840283403897VySpan™VY SPINE LLCKWP2026-06-05
00840283403927VySpan™VY SPINE LLCKWP2026-06-05
M711BTA2020Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-06-05
M711LS7490Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-06-05
00197157081515ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081522ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081539ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081546ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081553ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081560ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081577ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081584ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081591ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081607ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081614ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081621ZAVATION SCREWZavation LLCKWP2026-06-04
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00197157081645ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081652ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081669ZAVATION SCREWZavation LLCKWP2026-06-04