FDA.reportPublic FDA data

RAPHAEL Pedicle Screw System

Primary DI
00841732106567
Brand
RAPHAEL Pedicle Screw System
Company
CTL Medical Corporation
Model
015.3245
Device description
RAPHAEL™ Polyaxial Screw, 6.5 x L45mm
Published
2016-03-05
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132365000SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATIONAccel Spine2013-08-20MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732106567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732106567008417321065678417321065670841732106567

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length45Millimeter

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
00841732144521VALEO II PL OL Interbody Fusion System11.113.45132023-09-22
00841732145474VALEO II PL OL Interbody Fusion System11.113.45092023-09-22
00841732155381VALEO II PL OL Interbody Fusion System11.113.38102023-09-22
00841732155404VALEO II PL OL Interbody Fusion System11.113.38132023-09-22
00841732155411VALEO II PL OL Interbody Fusion System11.113.38142023-09-22
00841732155428VALEO II PL OL Interbody Fusion System11.113.38152023-09-22
00841732155435VALEO II PL OL Interbody Fusion System11.113.45082023-09-22
00841732155442VALEO II PL OL Interbody Fusion System11.113.45102023-09-22
00841732155459VALEO II PL OL Interbody Fusion System11.113.45112023-09-22
00841732155466VALEO II PL OL Interbody Fusion System11.113.45142023-09-22
00841732155923VALEO II PL OL Interbody Fusion System11.113.60072023-09-22
00841732155930VALEO II PL OL Interbody Fusion System11.113.60082023-09-22
00841732155947VALEO II PL OL Interbody Fusion System11.113.60092023-09-22
00841732155954VALEO II PL OL Interbody Fusion System11.113.60102023-09-22
00841732155961VALEO II PL OL Interbody Fusion System11.113.60112023-09-22
00841732155978VALEO II PL OL Interbody Fusion System11.113.60132023-09-22
00841732160200VALEO II PL OL Interbody Fusion System11.113.38112023-09-22
00841732155268VALEO II PL OL Interbody Fusion System11.113.18122023-09-21
00841732155275VALEO II PL OL Interbody Fusion System11.113.18132023-09-21
00841732155299VALEO II PL OL Interbody Fusion System11.113.18152023-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700780634583Erisma®-LPCLARIANCEMNH2026-05-28
03700780634583Erisma®-LPCLARIANCEMNI2026-05-28
04052536085491neon3Ulrich GmbH & Co. KGKWP2026-05-28
07613153143734XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143734XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613153143734XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153045670XIA IStryker CorporationMNH2014-12-08
07613153045670XIA IStryker CorporationKWP2014-12-08
07613153045700XIA IStryker CorporationKWP2014-12-08
07613153045700XIA IStryker CorporationMNI2014-12-08
07613153045700XIA IStryker CorporationMNH2014-12-08
07613153045717XIA IStryker CorporationKWP2014-12-08
07613153045717XIA IStryker CorporationMNH2014-12-08
07613153045717XIA IStryker CorporationMNI2014-12-08
07613153045724XIA IStryker CorporationMNI2014-12-08
07613153045724XIA IStryker CorporationKWP2014-12-08
07613153045731XIA IStryker CorporationMNI2014-12-08
07613153045731XIA IStryker CorporationMNH2014-12-08
07613153045731XIA IStryker CorporationKWP2014-12-08
07613153045748XIA IStryker CorporationMNH2014-12-08
07613153045748XIA IStryker CorporationMNI2014-12-08
07613153045755XIA IStryker CorporationMNH2014-12-08
07613153045755XIA IStryker CorporationKWP2014-12-08