FDA.reportPublic FDA data

Meduloc Intramedullary Fracture Fixation (IFF) System

Primary DI
00810184540267
Brand
Meduloc Intramedullary Fracture Fixation (IFF) System
Company
MEDULOC, LLC
Model
90-IFF-071020
Catalog number
90-IFF-071020
Device description
Cannulated Drill (2.0)
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
00810184540267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810184540267008101845402678101845402670810184540267

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
00810184540175Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-16002590-IFF-1600252026-01-14
00810184540182Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-16003090-IFF-1600302026-01-14
00810184540199Meduloc Intramedullary Fracture Fixation (IFF) System90-IFF-16003590-IFF-1600352026-01-14

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Primary DI, Brand, Company table
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00190776404192MillenniumAvalign Technologies, Inc.LXH2026-07-24
00810135961271ToejackNVision Biomedical Technologies, Inc.LXH2026-07-24
00840314263261gSourceGSOURCE LLCLXH2026-07-24
00840314263278gSourceGSOURCE LLCLXH2026-07-24
00840314263285gSourceGSOURCE LLCLXH2026-07-24
00840314263353gSourceGSOURCE LLCLXH2026-07-24
00840314263421gSourceGSOURCE LLCLXH2026-07-24
00840314263704gSourceGSOURCE LLCLXH2026-07-24
00840314263773gSourceGSOURCE LLCLXH2026-07-24
00840314263841gSourceGSOURCE LLCLXH2026-07-24
00889024709195DRILL MEASURING SLEEVEBiomet Orthopedics, LLCLXH2026-07-24
07640221373694SCALASpineArt SALXH2026-07-24
07640221373700SCALASpineArt SALXH2026-07-24
10886982362179NASynthes GmbHLXH2026-07-24
B382SD9141071020Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071030Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071040Surgical DirectSurgical Direct, Inc.LXH2026-07-24
00840097534206Velora Acetabular System InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534923Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
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00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21