FDA.reportPublic FDA data

VOLT™ Wrist Treatment System

Primary DI
00196449023363
Brand
VOLT™ Wrist Treatment System
Company
Tyber Medical, LLC
Model
03.424.303
Catalog number
03.424.303
Device description
Cannulated Screwdriver Shaft T8/Quick Coupling/105mm
Published
2025-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRZScrewdriver, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRZScrewdriver, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196449023363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449023363001964490233631964490233630196449023363

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
010968002
Device count
1
DM exempt
true
Premarket exempt
true
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
00196449002511LEOS Cannulated Screw System76312008763120082023-12-08
00196449002528LEOS Cannulated Screw System76312010763120102023-12-08
00196449002535LEOS Cannulated Screw System76312012763120122023-12-08
00196449002542LEOS Cannulated Screw System76312014763120142023-12-08
00196449002559LEOS Cannulated Screw System76312016763120162023-12-08
00196449002566LEOS Cannulated Screw System76312018763120182023-12-08
00196449002573LEOS Cannulated Screw System76312020763120202023-12-08
00196449002580LEOS Cannulated Screw System76312022763120222023-12-08
00196449002597LEOS Cannulated Screw System76312024763120242023-12-08
00196449002603LEOS Cannulated Screw System76312026763120262023-12-08
00196449002610LEOS Cannulated Screw System76312028763120282023-12-08
00196449002627LEOS Cannulated Screw System76312030763120302023-12-08
00196449002634LEOS Cannulated Screw System76312508763125082023-12-08
00196449002641LEOS Cannulated Screw System76312510763125102023-12-08
00196449002658LEOS Cannulated Screw System76312512763125122023-12-08
00196449002665LEOS Cannulated Screw System76312514763125142023-12-08
00196449002672LEOS Cannulated Screw System76312516763125162023-12-08
00196449002689LEOS Cannulated Screw System76312518763125182023-12-08
00196449002696LEOS Cannulated Screw System76312520763125202023-12-08
00196449002702LEOS Cannulated Screw System76312522763125222023-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B8034500040ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034709510ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034709530ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034709540ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034709560ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034709580ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034709610ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803480ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803490ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803500ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803520ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803530ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803540ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803550ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803560ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803580ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803600ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803620ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
00196449017348A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017379A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017386A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017393A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017454A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017553A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00841731137951TITANEX VILEX LLCLRZ2026-05-15
00841731137968TITANEX VILEX LLCLRZ2026-05-15
00841731138149TITANEX VILEX LLCLRZ2026-05-15
00841731140784TITANEX VILEX LLCLRZ2026-05-15
00841731141927TITANEX VILEX LLCLRZ2026-05-15
00841731146816TITANEX VILEX LLCLRZ2026-05-15