FDA.reportPublic FDA data

Meduloc Intramedullary Fracture Fixation (IFF) System

Primary DI
00810184540427
Brand
Meduloc Intramedullary Fracture Fixation (IFF) System
Company
MEDULOC, LLC
Model
90-IFF-400900
Catalog number
90-IFF-400900
Device description
Reusable Removal Tray
Published
2026-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810184540427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810184540427008101845404278101845404270810184540427

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
Serial number
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00196449010134Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035489Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035496Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035502Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035519Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035526Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00889024701670Identity® Shoulder SystemZimmer, Inc.FSM2026-06-09
04251047924804Sterilizing CaseA1 Medical GmbHFSM2026-06-09
04251047926389Sterilization Tray with LidA1 Medical GmbHFSM2026-06-09
04251047930386Double-level Sterilization TrayA1 Medical GmbHFSM2026-06-09
00810055257874Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257881Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257898Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257904Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257911Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257928Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257935Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257942Surgical DesignSurgical Design, Inc.FSM2026-06-06
00857915007750Endo ECTR TrayA.M. SURGICAL, INC.FSM2026-06-04
10705037042999STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FSM2026-06-03
07613327605716PANGEAStryker GmbHFSM2026-06-02
07613327623260MakoMAKO SURGICAL CORP.FSM2026-05-29
08435389830207STOP & GUIDE® BOXBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
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07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
07613327631852RPSSTRYKER CORPORATIONFSM2025-10-10
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07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03