FDA.reportPublic FDA data

Volt™ Wrist Treatment System

Primary DI
00196449023288
Brand
Volt™ Wrist Treatment System
Company
Tyber Medical, LLC
Model
03.426.601
Catalog number
03.426.601
Device description
Guide Block f/2Column Distal Radius Plate/Left/Standard
Published
2024-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232693000Tyber Medical Distal Radius Plating SystemTyber Medical, LLC2023-12-04HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196449023288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449023288001964490232881964490232880196449023288

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)761-0933nmerlini@tybermed.com

Regulatory Flags#

DUNS number
010968002
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00196449017348A.L.P.S. mvX™770001151A2026-06-04
00196449017355A.L.P.S. mvX™770002250A2026-06-04
00196449017362A.L.P.S. mvX™770002251A2026-06-04
00196449017379A.L.P.S. mvX™770001060A2026-06-04
00196449017386A.L.P.S. mvX™770001080A2026-06-04
00196449017393A.L.P.S. mvX™770001150A2026-06-04
00196449017409A.L.P.S. mvX™770002151A2026-06-04
00196449017416A.L.P.S. mvX™770002181A2026-06-04
00196449017423A.L.P.S. mvX™770002182A2026-06-04
00196449017430A.L.P.S. mvX™770002200A2026-06-04
00196449017447A.L.P.S. mvX™770002201A2026-06-04
00196449017454A.L.P.S. mvX™770001040A2026-06-04
00196449017461A.L.P.S. mvX™770002090A2026-06-04
00196449017478A.L.P.S. mvX™770002100A2026-06-04
00196449017485A.L.P.S. mvX™770002150A2026-06-04
00196449017492A.L.P.S. mvX™770002180A2026-06-04
00196449017508A.L.P.S. mvX™770003200A2026-06-04
00196449017515A.L.P.S. mvX™770003240A2026-06-04
00196449017522A.L.P.S. mvX™770003270A2026-06-04
00196449017539A.L.P.S. mvX™770003350A2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810022403433LinkBio InstrumentLink Bio CorpHWT2026-06-08
00810022403440LinkBio InstrumentLink Bio CorpHWT2026-06-08
00810022403457LinkBio InstrumentLink Bio CorpHWT2026-06-08
04048844758219EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758233EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758271EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758295EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758776n/aimplantcast GmbHHWT2026-06-02
04048844758820n/aimplantcast GmbHHWT2026-06-02
04048844758950n/aimplantcast GmbHHWT2026-06-02
04048844770747n/aimplantcast GmbHHWT2026-06-02
04048844770808n/aimplantcast GmbHHWT2026-06-02
04048844770891n/aimplantcast GmbHHWT2026-06-02
04048844770938n/aimplantcast GmbHHWT2026-06-02
04048844770952n/aimplantcast GmbHHWT2026-06-02
04048844770976n/aimplantcast GmbHHWT2026-06-02
00850011453544REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCHWT2026-06-01
10603295552680ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555001ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555018ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555025ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555032ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555049ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555056ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555544ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555582ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10885862660527AcuMatchExactech, Inc.HWT2026-05-28
10885862660541AcuMatchExactech, Inc.HWT2026-05-28
10885862660558AcuMatchExactech, Inc.HWT2026-05-28
10885862660565AcuMatchExactech, Inc.HWT2026-05-28