FDA.reportPublic FDA data

Versalock Proximal Tibial Plating System

Primary DI
07899258606682
Brand
Versalock Proximal Tibial Plating System
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
CANCELLOUS SCREW Ø3.5x20.0mm
Catalog number
169-35-20
Published
2026-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899258606682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258606682078992586066827899258606682

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
900865213
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07901125609020Orthopedic InstrumentsVERSALOCK ANKLE SYSTEM BOX - FOR USA314-70102026-08-17
07899258663241ACCESS FITSTRAIGHT SUTURE PASSER359-2002024-08-13
07899258663258ACCESS FITRIGHT SUTURE PASSER359-2102024-08-13
07899258663265ACCESS FITLEFT SUTURE PASSER359-2202024-08-13
07899258658292Meniscus Suture - OUT INMeniscus Suture - OUT IN354-100-0502024-01-18
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188132452Tools - TWFTrimed, INC.HRS2026-08-18
00842188132230Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132247Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132254Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132261Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132445Tools - TWFTrimed, INC.HRS2026-08-17
00193982096274ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982096274ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982096298ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982096298ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982096311ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982096311ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101909ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101909ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101923ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101923ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101947ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101947ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158323ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158323ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158378ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158378ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158422ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158422ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158477ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158477ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158521ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158521ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158576ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158576ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14