FDA.reportPublic FDA data

VOLT™ Wrist Treatment System

Primary DI
00196449019656
Brand
VOLT™ Wrist Treatment System
Company
Tyber Medical, LLC
Model
02.426.830S
Catalog number
02.426.830S
Device description
2.4/2.7 Vlr Rim Dist Radius Plate 6Head/3Shft/Right/Std/60mm
Published
2025-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196449019656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449019656001964490196561964490196560196449019656

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. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
010968002
Device count
1
DM exempt
true
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
00196449017645Anatomic Access LLIF818000362026-06-23
00196449035373Anatomic Access LLIF818000132026-06-23
00196449010134Anatomic Access LLIF818000292026-06-09
00196449010196Anatomic Access LLIF818000342026-06-09
00196449010288Anatomic Access LLIF818000352026-06-09
00196449035243Anatomic Access LLIF818000002026-06-09
00196449035250Anatomic Access LLIF818000012026-06-09
00196449035267Anatomic Access LLIF818000022026-06-09
00196449035281Anatomic Access LLIF818000042026-06-09
00196449035298Anatomic Access LLIF818000052026-06-09
00196449035304Anatomic Access LLIF818000062026-06-09
00196449035311Anatomic Access LLIF818000072026-06-09
00196449035328Anatomic Access LLIF818000082026-06-09
00196449035335Anatomic Access LLIF818000092026-06-09
00196449035366Anatomic Access LLIF818000122026-06-09
00196449035380Anatomic Access LLIF818000142026-06-09
00196449035397Anatomic Access LLIF818000152026-06-09
00196449035441Anatomic Access LLIF818000202026-06-09
00196449035465Anatomic Access LLIF818000222026-06-09
00196449035472Anatomic Access LLIF818000232026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894822858APTUSMedartis AGHRS2026-07-16
07630894822865APTUSMedartis AGHRS2026-07-16
07630894822872APTUSMedartis AGHRS2026-07-16
07630894822889APTUSMedartis AGHRS2026-07-16
07630894822896APTUSMedartis AGHRS2026-07-16
07630894822902APTUSMedartis AGHRS2026-07-16
07630894822919APTUSMedartis AGHRS2026-07-16
07630894822926APTUSMedartis AGHRS2026-07-16
07630894822933APTUSMedartis AGHRS2026-07-16
07630894822940APTUSMedartis AGHRS2026-07-16
07630894822957APTUSMedartis AGHRS2026-07-16
07630894822964APTUSMedartis AGHRS2026-07-16
07630894822971APTUSMedartis AGHRS2026-07-16
07630894822988APTUSMedartis AGHRS2026-07-16
07630894822995APTUSMedartis AGHRS2026-07-16
07630894823008APTUSMedartis AGHRS2026-07-16
07630894823015APTUSMedartis AGHRS2026-07-16
07630894823022APTUSMedartis AGHRS2026-07-16
07630894823039APTUSMedartis AGHRS2026-07-16
07630894823053APTUSMedartis AGHRS2026-07-16
07630894823060APTUSMedartis AGHRS2026-07-16
07630894823084APTUSMedartis AGHRS2026-07-16
07630894823091APTUSMedartis AGHRS2026-07-16
07630894823114APTUSMedartis AGHRS2026-07-16
07630894823121APTUSMedartis AGHRS2026-07-16
07630894823145APTUSMedartis AGHRS2026-07-16
07630894823152APTUSMedartis AGHRS2026-07-16
07630894823176APTUSMedartis AGHRS2026-07-16
07630894823183APTUSMedartis AGHRS2026-07-16
07630894823206APTUSMedartis AGHRS2026-07-16