FDA.reportPublic FDA data

Versalock Periprosthetic Femur Plates System-GMReis

Primary DI
07899258600673
Brand
Versalock Periprosthetic Femur Plates System-GMReis
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
VA Screw
Catalog number
327-50-65
Device description
VERSALOCK VARIABLE ANGLE SCREW T25 Ø5.0x65.0mm Ti
Published
2024-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDPCondylar Plate Fixation ImplantOrthopedic2
JDQCerclage, FixationOrthopedic2

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
07899258600673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258600673078992586006737899258600673

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
07899258696058Orthopedic Instruments180-1602026-09-29
07901125621138Orthopedic Instruments180-381-AO2026-09-29
07901125621145Orthopedic Instruments180-382-AO2026-09-29
07901125621312Orthopedic Instruments342-01152026-09-29
07901125621329Orthopedic Instruments342-01202026-09-29
07901125621336Orthopedic Instruments342-01542026-09-29
07901125621350Orthopedic Instruments180-ES-SP-02-FU2026-09-29
07901125621398Orthopedic Instruments352-1032026-09-29
07899258601670Orthopedic Instruments339-CX-262026-09-24
07901125621176Versalock Mini and Micro Plating System308-15-17-B-BL2026-09-18
07901125621183Versalock Mini and Micro Plating System308-15-19-B-BL2026-09-18
07901125621190Versalock Mini and Micro Plating System308-15-21-B-BL2026-09-18
07901125621206Versalock Mini and Micro Plating System308-15-23-B-BL2026-09-18
07899258654799Stitch - Suture Wires and Tapes333-239-AB1226CI2026-08-27
07899258654805Stitch - Suture Wires and Tapes333-239-PB1226CI2026-08-27
07899258654812Stitch - Suture Wires and Tapes333-20-B2026-08-27
07899258654829Stitch - Suture Wires and Tapes333-20-AB2026-08-27
07899258657141Stitch - Suture Wires and Tapes333-239-B1226CI2026-08-27
07899258665764Stitch - Suture Wires and Tapes333-536-AB1248CO2026-08-27
07899258665771Stitch - Suture Wires and Tapes333-536-B1248CO2026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867627840Arthrex®ARTHREX, INC.HWC2026-10-07
00888867627857Arthrex®ARTHREX, INC.HWC2026-10-07
00888867627864Arthrex®ARTHREX, INC.HWC2026-10-07
05055662976649Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976656Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976663Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976670Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976687Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
03700569631840Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
03700569631857Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
03700569633943NANEWCLIP TECHNICSHWC2026-10-01
03700569633967NANEWCLIP TECHNICSHWC2026-10-01
03700569633981NANEWCLIP TECHNICSHWC2026-10-01
03700569634001NANEWCLIP TECHNICSHWC2026-10-01
03700569634025NANEWCLIP TECHNICSHWC2026-10-01
03700569634049NANEWCLIP TECHNICSHWC2026-10-01
03700569634063NANEWCLIP TECHNICSHWC2026-10-01
10806378125997ACUMEDAcumed LLCHWC2025-12-08
10806378126000ACUMEDAcumed LLCHWC2025-12-08
10806378126017ACUMEDAcumed LLCHWC2025-12-08
10806378126024ACUMEDAcumed LLCHWC2025-12-08
10806378126031ACUMEDAcumed LLCHWC2025-12-08
10806378126048ACUMEDAcumed LLCHWC2025-12-08
10806378126055ACUMEDAcumed LLCHWC2025-12-08
10806378126062ACUMEDAcumed LLCHWC2025-12-08
10806378126079ACUMEDAcumed LLCHWC2025-12-08
10806378126086ACUMEDAcumed LLCHWC2025-12-08
10806378126093ACUMEDAcumed LLCHWC2025-12-08
10806378126109ACUMEDAcumed LLCHWC2025-12-08
10806378126116ACUMEDAcumed LLCHWC2025-12-08