FFX 13x3.5

Primary DI
03770019503058
Brand
FFX 13x3.5
Company
SC MEDICA
Model
57.000.60S
Device description
The FFX implant is a sterile, single patient use, long-term implantable devices consisting of a D-shaped cage made of titanium with an oval shape that is designed to be filled with bone graft. The top and bottom surfaces of the cage have sawtooth-shaped surface to improve fixation to the bone.
Published
2024-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MRWSystem, Facet Screw Spinal Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232468000SC Medica FFXSc Medica2024-05-09MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770019503058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770019503058037700195030583770019503058

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

Regulatory Flags#

DUNS number
267135902
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760418040667FFX Screw 58.540.22S2025-11-26
03760418040674FFX Screw 58.540.20S2025-11-26
03760418040681FFX Screw 58.540.18S2025-11-26
03760418040698FFX Screw 58.540.16S2025-11-26
03760418040704FFX Screw 58.535.22S2025-11-26
03760418040711FFX Screw 58.535.20S2025-11-26
03760418040728FFX Screw 58.535.18S2025-11-26
03760418040735FFX Screw 58.535.16S2025-11-26
03760418040742FFX Screw 58.525.22S2025-11-26
03760418040759FFX Screw 58.525.20S2025-11-26
03760418040766FFX Screw 58.525.18S2025-11-26
03760418040773FFX Screw 58.525.16S2025-11-26
03760418040896FFX Screw 58.540.14S2025-11-26
03760418040940FFX Screw 58.535.14S2025-11-26
03760418040995FFX Screw 58.525.14S2025-11-26
03770019503003FFX 11x2.557.000.10S2024-11-13
03770019503010FFX 13x2.557.000.20S2024-11-13
03770019503027FFX 11x357.000.30S2024-11-13
03770019503034FFX 13x357.000.40S2024-11-13
03770019503041FFX 11x3.557.000.50S2024-11-13

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Primary DI, Brand, Company table
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