FDA.reportPublic FDA data

PIRANHA

Primary DI
00840916143091
Brand
PIRANHA
Company
SPINAL ELEMENTS
Model
CSVS-425-18
Device description
Piranha, Rescue Variable Screw Ø 4.25mmx18mm
Published
2021-01-09
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
00840916143091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916143091008409161430918409161430910840916143091

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

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
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
00840916104092DIAMOND6-3-682017-05-23

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