FDA.reportPublic FDA data

Javelin

Primary DI
00810005662598
Brand
Javelin
Company
NVision Biomedical Technologies, Inc.
Model
TB-1000T-JG30
Device description
Instrument: 30mm Targeting Jig Drill Guide. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
Published
2021-02-02
Public version status
Update
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810005662598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810005662598008100056625988100056625980810005662598

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
210-545-3713diana@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
00810135961264ToejackTJB-1001T-SG052026-07-24
00810135961271ToejackTJB-1000T-JBCG2026-07-24
00810135961752ToejackTJB-1000T-PDS2026-07-24
00810005666855TrigonLD-050004T-282024-02-22
00810005666862TrigonLD-050006T-282024-02-22
00810005666985TrigonLDP-2408-04102024-02-22
00810005666992TrigonLDP-2408-04082024-02-22
00810005667005TrigonLDP-2408-04062024-02-22
00810005667012TrigonLDP-2408-04042024-02-22
00810005667029TrigonLDP-2408-02102024-02-22
00810005667036TrigonLDP-2408-02082024-02-22
00810005667043TrigonLDP-2408-02062024-02-22
00810005667050TrigonLDP-2408-02042024-02-22
00810005667067TrigonLDP-2408-00102024-02-22
00810005667074TrigonLDP-2408-00082024-02-22
00810005667081TrigonLDP-2408-00062024-02-22
00810005667098TrigonLDP-2408-00042024-02-22
00810005667104TrigonLDP-2405-04082024-02-22
00810005667111TrigonLDP-2405-04062024-02-22
00810005667128TrigonLDP-2405-04042024-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188132568Tools-AFSTrimed, INC.FZX2026-07-24
00841731153128ARTEMIS FUZEVILEX LLCFZX2026-07-22
00888118147226LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147233LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147240LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147257LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147264LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147271LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147714LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147721LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147738LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147745LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00810111228374Positioner / CompressorTreace Medical Concepts, Inc.FZX2026-07-17
00810111228381Positioner / CompressorTreace Medical Concepts, Inc.FZX2026-07-17
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18257200131204Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200131235Firebird SI FusionOrthofix US LLCFZX2026-07-17
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00190446948445Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948452Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
09421038412237KA Femoral Alignment GuideENZTEC LIMITEDFZX2026-06-24
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