FDA.reportPublic FDA data

Meduloc Intramedullary Fracture Fixation (IFF) System

Primary DI
00810184540175
Brand
Meduloc Intramedullary Fracture Fixation (IFF) System
Company
MEDULOC, LLC
Model
90-IFF-160025
Catalog number
90-IFF-160025
Device description
Locking Screwdriver (2.5)
Published
2026-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
00810184540175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810184540175008101845401758101845401750810184540175

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
111186753
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
00810184540007Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20001590-IFF-2000152026-01-14
00810184540014Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20051590-IFF-2005152026-01-14
00810184540021Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20002090-IFF-2000202026-01-14
00810184540038Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20052090-IFF-2005202026-01-14
00810184540045Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20002590-IFF-2000252026-01-14
00810184540052Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20052590-IFF-2005252026-01-14
00810184540069Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20003090-IFF-2000302026-01-14
00810184540076Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20053090-IFF-2005302026-01-14
00810184540083Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20003590-IFF-2000352026-01-14
00810184540090Meduloc Intramedullary Fracture Fixation (IFF) SystemPKG-90-IFF-20053590-IFF-2005352026-01-14
00810184540106Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-15001590-IFF-1500152026-01-14
00810184540113Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-15002090-IFF-1500202026-01-14
00810184540120Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-15002590-IFF-1500252026-01-14
00810184540137Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-15003090-IFF-1500302026-01-14
00810184540144Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-15003590-IFF-1500352026-01-14
00810184540151Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-16001590-IFF-1600152026-01-14
00810184540168Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-16002090-IFF-1600202026-01-14
00810184540182Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-16003090-IFF-1600302026-01-14
00810184540199Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-16003590-IFF-1600352026-01-14
00810184540205Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-18001590-IFF-1800152026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17
00889929072219NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072226NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072233NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072264NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072271NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072288NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072295NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072301NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072318NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072325NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072332NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072349Matrixx SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072356NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072363NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072394NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072448Matrixx SystemNEXXT SPINE, LLCLXH2026-07-17