FDA.reportPublic FDA data

PIRANHA

Primary DI
00840916112608
Brand
PIRANHA
Company
SPINAL ELEMENTS
Model
CSF-425-16
Device description
Piranha Cervical Screw Ø 4.25mm x 16mm
Published
2017-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840916112608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916112608008409161126088409161126080840916112608

GMDN Terms#

Term, Definition table
TermDefinition
Cervical total disc replacement prosthesis, non-sterileA non-sterile implantable device designed to replace most or all of a dysfunctional intervertebral disc in the cervical spine. It is made of synthetic polymer material(s) [e.g., polyetheretherketone (PEEK)] and typically has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below, to facilitate motion usually through the sliding action of its smooth surfaces. This device is intended to be sterilized before use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004022104
Device count
1
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
00840916123710ZEUS-T67-2811122017-08-01
00840916162115DIAMOND100402022-03-03
00840916162122DIAMOND100432022-03-03
00840916162139DIAMOND100472022-03-03
00840916142926ZEUS-O101122021-01-11
00840916143008ZEUS-O109972021-01-11
00840916160135SPARTAN103132020-12-07
00840916156947ZEUS-O105002020-05-11
00840916117603SLPSS82192017-08-10
00840916149840SAVANNAH91052020-04-16
00840916150143SAVANNAH82712020-04-16
00840916150150SAVANNAH90012020-04-16
00840916150167SAVANNAH90022020-04-16
00840916150174SAVANNAH90042020-04-16
00840916150211SAVANNAH90502020-04-16
00840916150228SAVANNAH90902020-04-16
00840916115555SAMSON135142017-08-01
00840916115562SAMSON135152017-08-01
00840916115579SAMSON135162017-08-01
00840916115586SAMSON135172017-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857037953EVEREST® Spinal SystemVB Spine LLCMNH2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCMNH2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857046733MESA® Small Stature Spinal SystemVB Spine LLCMNH2016-09-02
10888857008724EVEREST® Spinal SystemVB Spine LLCMNH2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001763DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001787DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001824DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001848DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001923DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001947DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001978DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001992DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857002036DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857002050DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857002074DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857002098DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24