FDA.reportPublic FDA data

PIRANHA

Primary DI
00840916112677
Brand
PIRANHA
Company
SPINAL ELEMENTS
Model
CSV-425-14
Device description
Piranha Cervical Variable Screw Ø 4.25mm x 14mm
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
00840916112677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916112677008409161126778409161126770840916112677

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
00840916143084PIRANHACSVS-425-162021-01-09
00840916143091PIRANHACSVS-425-182021-01-09
00840916135119BLACK WIDOWTBS0452021-01-07
00840916135126BLACK WIDOWTBS0502021-01-07
00840916135133BLACK WIDOWTBS0552021-01-07
00840916103941DIAMOND6-1-302017-05-23
00840916103958DIAMOND6-1-322017-05-23
00840916103965DIAMOND6-1-342017-05-23
00840916103972DIAMOND6-2-362017-05-23
00840916103989DIAMOND6-2-392017-05-23
00840916103996DIAMOND6-2-422017-05-23
00840916104009DIAMOND6-2-452017-05-23
00840916104016DIAMOND6-2-482017-05-23
00840916104023DIAMOND6-2-512017-05-23
00840916104030DIAMOND6-3-532017-05-23
00840916104047DIAMOND6-2-542017-05-23
00840916104054DIAMOND6-3-562017-05-23
00840916104061DIAMOND6-3-592017-05-23
00840916104078DIAMOND6-3-622017-05-23
00840916104085DIAMOND6-3-652017-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311244874Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244881Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244904Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244928Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244935Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244942Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245017Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245024Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245062Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245079Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245130Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245154Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245161Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245185Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245208Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245222Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245239Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245253Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245284Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245345Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245369Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245970Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246007Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246014Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246045Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246113Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246175Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246250Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246267Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246298Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03