FDA.reportPublic FDA data

Super Upper Limbs Versalock Plating System

Primary DI
07899258697123
Brand
Super Upper Limbs Versalock Plating System
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
VERSALOCK 1.5mm SCAPHOID MICRO PLATE, LARGE
Catalog number
308-252
Device description
VERSALOCK 1.5mm SCAPHOID MICRO PLATE, LARGE
Published
2025-09-22
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899258697123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258697123078992586971237899258697123

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, and may be used in connection with another fixation plate; 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
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
14053613298657KOMET GUIDE PIN/SCREWGebr. Brasseler GmbH & Co. KGHWC2026-10-14
00888118131867LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.HRS2026-04-23
00888118132529LEVEL ONE EXTREMITYKLS-Martin L.P.HRS2026-04-23
08057717550009BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550016BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550023BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550030BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550047BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550061BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550290BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550313BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550252BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-08
08057717550276BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-08
B650SCS370450StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370500StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370550StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370600StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370650StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370700StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370750StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370800StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370850StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370900StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830700StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830750StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830800StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830850StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830900StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830950StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX831000StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31