FDA.reportPublic FDA data

FFX holder

Primary DI
03760418040179
Brand
FFX holder
Company
SC MEDICA
Model
57.001.30N
Device description
Holder for FFX with tips
Published
2024-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760418040179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760418040179037604180401793760418040179

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
267135902
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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M7403030030Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030031Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030032Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030033Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030034Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030035Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030036Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030059Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030060Discectomy SetSPINEOLOGY INC.LXH2026-05-28
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