FDA.reportPublic FDA data

CASSATT SIJ Fixation System

Primary DI
00841732145702
Brand
CASSATT SIJ Fixation System
Company
CTL Medical Corporation
Model
133.2240
Device description
D12.5 x L40mm, CT45, Lag-Loc Screw, Cannulated
Published
2025-05-29
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
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211785000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211785000CASSATT™ SIJ Fixation SystemCtl Medical Corporation2022-10-17OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732145702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732145702008417321457028417321457020841732145702

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
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
00841732135024MONDRIAN ALIF Cage with Supplementary Fixation Plate120.75002025-03-31
00841732141049MONDRIAN ALIF Cage with Supplementary Fixation Plate120.75022025-03-31
00841732142206GENERIC Surgical Instruments120.75082025-03-31
00841732142213MONDRIAN ALIF Cage with Supplementary Fixation Plate120.75102025-03-31
00841732142220MONDRIAN ALIF Cage with Supplementary Fixation Plate120.75202025-03-31
00841732142237MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76052025-03-31
00841732142244MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76092025-03-31
00841732142251MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76112025-03-31
00841732142268MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76132025-03-31
00841732142275MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76152025-03-31
00841732142282MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76172025-03-31
00841732142299MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76192025-03-31
00841732142305MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76212025-03-31
00841732142312GENERIC Surgical Instruments120.77002025-03-31
00841732142329GENERIC Surgical Instruments120.77012025-03-31
00841732142336GENERIC Surgical Instruments120.77022025-03-31
00841732142343GENERIC Surgical Instruments120.77102025-03-31
00841732142350GENERIC Surgical Instruments120.77202025-03-31
00841732142367GENERIC Surgical Instruments120.77252025-03-31
00841732142374GENERIC Surgical Instruments120.77302025-03-31

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