FDA.reportPublic FDA data

Versalock Periprosthetic Femur Plates System-GMReis

Primary DI
07899258657806
Brand
Versalock Periprosthetic Femur Plates System-GMReis
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Condilar Plate
Catalog number
327-09-D
Device description
MIS VERSALOCK CONDYLAR FEMUR PLATE 09H - RIGHT
Published
2024-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone
JDPCondylar Plate Fixation Implant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDPCondylar Plate Fixation ImplantOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201728000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201728000Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda.2021-03-08HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899258657806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258657806078992586578067899258657806

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
900865213
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899258616506Orthopedic InstrumentsSYNDESMOSIS CLAMP314-1002026-07-07
07899258625348Orthopedic InstrumentsGUIDE WIRE Ø1.0x190.0mm WITHOUT THREAD106-812026-07-07
07899258625355Orthopedic Instruments1,0x190mm THREADED GUIDE WIRE106-822026-07-07
07899258633350Orthopedic InstrumentsGUIDE DRILL DOUBLE 2,7mm106-852026-07-07
07899258633367Orthopedic Instruments4.0mm CANCELLOUS TAP106-862026-07-07
07899258633374Orthopedic InstrumentsSMALL DEPTH GAUGE106-872026-07-07
07899258633381Orthopedic InstrumentsØ1.0x250.0mm WIRE106-882026-07-07
07899258634388Orthopedic InstrumentsSCREW EXTRACTOR 3.5mm169-4252026-07-07
07899258636290Orthopedic InstrumentsØ3.2mm WIRE CUTTING FORCEPS172-19A2026-07-07
07899258645094Orthopedic InstrumentsSCREW DRIVER TIP HEXALOBULAR T15 FIT AO307-1102026-07-07
07899258646527Orthopedic Instruments1.0x20.0x100.0mm GUIDE WIRE WITH SPHERICAL STOP223-3062026-07-07
07899258655864Orthopedic InstrumentsINSTRUMENTAL TRAY FOR ANKLE FRACTURE314-70022026-07-07
07899258655871Orthopedic InstrumentsIMPLANT TRAY TO ANKLE FRACTURE314-70042026-07-07
07899258655932Orthopedic InstrumentsVERSALOCK SYSTEM KIT FOR ANKLE314-70012026-07-07
07899258655949Orthopedic InstrumentsANKLE FRACTURE IMPLANT TRAY314-70032026-07-07
07899258656151Orthopedic InstrumentsIDENTIFICATION AND ORIENTATION PANEL314-70082026-07-07
07899258695464Orthopedic InstrumentsVERSA AND VERSALOCK SCREW CASES Ø2.7mm AND Ø3.5mm314-70052026-07-07
07899258695471Orthopedic InstrumentsMINI CANNULATED SCREW CASE Ø4.0mm AND DEDICATED IN314-70062026-07-07
07899258695488Orthopedic InstrumentsVERSALOCK MINI PLATE CASE314-70072026-07-07
07901125601130GMReis Suture AnchorsFASTLOCK - KNOTLESS PEEK ANCHOR Ø4.75x15.0/19.1mm 320-475191-PE3H2026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446944331Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446944348Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952213Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952220Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952237Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952244Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952251Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952268Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952275Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952282Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952299Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952305Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952312Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952329Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00885556904879EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556904923EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906163EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906170EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906187EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906194EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906200EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906217EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906224EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906231EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906248EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906255EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906262EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906279EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906286EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906293EVOSSmith & Nephew, Inc.HWC2026-06-25