FDA.reportPublic FDA data

Vertex

Primary DI
00810005667258
Brand
Vertex
Company
NVision Biomedical Technologies, Inc.
Model
STK-1000T-001
Device description
Instrument: sizing guide body is 08-10 (multiple use). The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The Vertex bone staples are made from superelastic nitinol that does not require cold storage or heating.
Published
2020-12-28
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182943000VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC2019-04-04JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810005667258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810005667258008100056672588100056672580810005667258

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
false
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
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
00810005667135TrigonLDP-2405-02082024-02-22
00810005667142TrigonLDP-2405-02062024-02-22
00810005667159TrigonLDP-2405-02042024-02-22

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Primary DI, Brand, Company table
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