FDA.reportPublic FDA data

Toejack

Primary DI
00810135961264
Brand
Toejack
Company
NVision Biomedical Technologies, Inc.
Model
TJB-1001T-SG05
Device description
Drill and Screw Guide Holding Screw Drill and Screw Guide, 5mm
Published
2026-07-24
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810135961264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810135961264008101359612648101359612640810135961264

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 210-598-5648anikajosephsmith@nvisionbiomed.com

Regulatory Flags#

DUNS number
047486041
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00810005663762ToejackTB-30-20L2026-07-29
00810005663779ToejackTB-30-22L2026-07-29
00810005665711ToejackTB-30-18L2026-07-29
00810005668828TrigonTB-30-18N2026-07-29
00810005668835ToeJackTB-30-20N2026-07-29
00810005668842ToejackTB-30-22N2026-07-29
00810135961196ToeJackTJB-30-302026-07-29
00810135961202ToejackTJB-1000T-D30S2026-07-29
00810135961219ToejackTJB-1000T-D30C2026-07-29
00810135961226ToejackTJB-1000T-T8CI2026-07-29
00810135961233ToejackTJB-1001T-DPG2026-07-29
00810135961257ToejackTJB-1001T-SG032026-07-29
00810135961288ToejackTJB-1000T-PKS2026-07-29
00810135961769ToejackTJB-30-14HL2026-07-29
00810135961776ToejackTJB-30-16HL2026-07-29
00810135961783ToejackTJB-30-18HL2026-07-29
00810135961790ToejackTJB-30-20HL2026-07-29
00810135961806ToejackTJB-30-22HL2026-07-29
00810135963121ToeJack Bunion Correction SystemTJB-1000C-1052026-07-29
00810135965088ToeJack Bunion Correction SystemTJB-1000C-1042026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09353903030461OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-11-04
09353903030478OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-11-04
00841731133519REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133526REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133533REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133540REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133557REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133694REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00889024713727G7® TM Acetabular SystemZimmer, Inc.HTW2026-11-03
00713864000313EF1Medshape, Inc.HTW2026-11-02
00713864000320EF1Medshape, Inc.HTW2026-11-02
07630894822513APTUSMedartis AGHTW2026-11-02
07630894822520APTUSMedartis AGHTW2026-11-02
07630894822605APTUSMedartis AGHTW2026-11-02
07630894822612APTUSMedartis AGHTW2026-11-02
07630894822667APTUSMedartis AGHTW2026-11-02
07630894822674APTUSMedartis AGHTW2026-11-02
03700569679279Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
03700569679286Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
03700569679293Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
03700569679309Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
00842078100363IO FiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078100370IO FiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078100387IO FiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078101773XMCPEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078103197IO FiX 2.0EXTREMITY MEDICAL, LLCHTW2026-10-29
00842078103227IO FiX 2.0EXTREMITY MEDICAL, LLCHTW2026-10-29
00842078109465CarpalFiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078110379AlignXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078112304Axis BeamsEXTREMITY MEDICAL, LLCHTW2026-10-29