FDA.reportPublic FDA data

Versalock Periprosthetic Femur Plates System-GMReis

Primary DI
07899258654959
Brand
Versalock Periprosthetic Femur Plates System-GMReis
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Distal Femur Plate
Catalog number
282-14-D
Device description
VERSALOCK DISTAL FEMUR PERIPROSTHETIC PLATE 21H – RIGHT
Published
2024-01-17
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
07899258654959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258654959078992586549597899258654959

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
07899258606637Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x10.0mm169-35-102026-07-30
07899258606644Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x12.0mm169-35-122026-07-30
07899258606651Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x14.0mm169-35-142026-07-30
07899258606668Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x16.0mm169-35-162026-07-30
07899258606675Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x18.0mm169-35-182026-07-30
07899258606682Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x20.0mm169-35-202026-07-30
07899258606699Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x22.0mm169-35-222026-07-30
07899258606705Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x24.0mm169-35-242026-07-30
07899258606712Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x26.0mm169-35-262026-07-30
07899258606729Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x28.0mm169-35-282026-07-30
07899258606736Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x30.0mm169-35-302026-07-30
07899258606743Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x32.0mm169-35-322026-07-30
07899258606750Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x34.0mm169-35-342026-07-30
07899258606767Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x35.0mm169-35-352026-07-30
07899258606774Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x36.0mm169-35-362026-07-30
07899258606781Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x38.0mm169-35-382026-07-30
07899258606798Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x40.0mm169-35-402026-07-30
07899258606804Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x42.0mm169-35-422026-07-30
07899258606811Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x44.0mm169-35-442026-07-30
07899258606828Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x45.0mm169-35-452026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899258606637Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606637Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606644Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606644Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606651Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606651Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606668Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606668Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606675Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606675Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606682Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606682Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606699Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606699Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606705Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606705Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606712Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606712Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606729Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606729Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606736Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606736Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606743Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606743Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606750Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606750Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606767Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606767Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606774Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606774Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30