FDA.reportPublic FDA data

Meduloc Intramedullary Fracture Fixation (IFF) System

Primary DI
00810184540458
Brand
Meduloc Intramedullary Fracture Fixation (IFF) System
Company
MEDULOC, LLC
Model
90-IFF-190015
Catalog number
90-IFF-190015
Device description
Removal Trephine (1.5)
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
00810184540458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810184540458008101845404588101845404580810184540458

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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00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500040Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500050Surgical DirectSurgical Direct, Inc.LXH2026-07-09