FDA.reportPublic FDA data

RAPHAEL Pedicle Screw System

Primary DI
00841732108202
Brand
RAPHAEL Pedicle Screw System
Company
CTL Medical Corporation
Model
015.8701
Device description
RAPHAEL™ Pedicle Screw System Instrument Case, Cannulated
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
KWPAppliance, Fixation, Spinal Interlaminal
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
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
00841732108202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732108202008417321082028417321082020841732108202

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
00841732162792VALEO91.002.10052024-10-02
00841732151024PREFERENCE Pedicle Screw System10-2900-0452024-09-27
00841732151031PREFERENCE Pedicle Screw System10-2900-0552024-09-27
00841732151048PREFERENCE Pedicle Screw System10-2900-0702024-09-27
00841732151055PREFERENCE Pedicle Screw System10-2900-0902024-09-27
00841732151062PREFERENCE Pedicle Screw System10-2961-5202024-09-27
00841732151079PREFERENCE Pedicle Screw System10-2961-5222024-09-27
00841732151086PREFERENCE Pedicle Screw System10-2961-5242024-09-27
00841732151093PREFERENCE Pedicle Screw System10-2961-5262024-09-27
00841732162761VALEO91.002.10022023-09-30
00841732162778VALEO91.002.10032023-09-30
00841732162785VALEO91.002.10042023-09-30
00841732162686VALEO TL Spacer System91.001.40012023-09-27
00841732162693VALEO TL Spacer System91.001.40022023-09-27
00841732162709GENERIC Surgical Instruments91.001.40052023-09-27
00841732162716GENERIC Surgical Instruments91.001.40152023-09-27
00841732162723VALEO TL Spacer System91.001.40162023-09-27
00841732162730VALEO TL Spacer System91.001.40292023-09-27
00841732162747VALEO TL Spacer System91.001.40382023-09-27
00841732162754GENERIC Surgical Instruments91.001.41152023-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449010134Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035489Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035496Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035502Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035519Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035526Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00889024701670Identity® Shoulder SystemZimmer, Inc.FSM2026-06-09
04052536163403neon3Ulrich GmbH & Co. KGKWP2026-06-09
04052536163410neon3Ulrich GmbH & Co. KGKWP2026-06-09
04251047924804Sterilizing CaseA1 Medical GmbHFSM2026-06-09
04251047926389Sterilization Tray with LidA1 Medical GmbHFSM2026-06-09
04251047930386Double-level Sterilization TrayA1 Medical GmbHFSM2026-06-09
04052536162109neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162123neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162185neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162192neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162208neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536194285neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536194292neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536194308neon3Ulrich GmbH & Co. KGKWP2026-06-08
00810055257874Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257881Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257898Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257904Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257911Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257928Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257935Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257942Surgical DesignSurgical Design, Inc.FSM2026-06-06
00197157082031ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082048ZAVATION SCREWZavation LLCKWP2026-06-05