Piranha

GUDID 00840916112646

Piranha Cervical Variable Screw Ø 4.0mm x 16mm

SPINAL ELEMENTS

Cervical total disc replacement prosthesis, non-sterile
Primary Device ID00840916112646
NIH Device Record Keyf7687393-4c61-426c-86bc-4d80db40c83c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePiranha
Version Model NumberCSV-40-16
Company DUNS004022104
Company NameSPINAL ELEMENTS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840916112646 [Primary]

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840916112646]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-25
Device Publish Date2017-07-11

On-Brand Devices [Piranha]

00840916112752Piranha, Rescue Variable Screw Ø 4.25mmx14mm
00840916112745Piranha, Rescue Variable Screw Ø 4.25mm x 12mm
00840916112738Piranha, Self Drilling Variable Screw Ø 4.0mmx18mm
00840916112721Piranha, Self Drilling Variable Screw Ø 4.0mmx16mm
00840916112714Piranha, Self Drilling Variable Screw Ø 4.0mmx14mm
00840916112707Piranha, Self Drilling Variable Screw Ø 4.0mmx12mm
00840916112691Piranha Cervical Screw Ø 4.25mm x 12mm
00840916112684Piranha Cervical Variable Screw Ø 4.25mm x 16mm
00840916112677Piranha Cervical Variable Screw Ø 4.25mm x 14mm
00840916112660Piranha Cervical Variable Screw Ø 4.25mm x 12mm
00840916112653Piranha Cervical Variable Screw Ø 4.0mm x 18mm
00840916112646Piranha Cervical Variable Screw Ø 4.0mm x 16mm
00840916112639Piranha Cervical Variable Screw Ø 4.0mm x 14mm
00840916112622Piranha Variable Screw Ø 4.0mm x 12mm
00840916112615Piranha Cervical Screw Ø 4.25mm x 18mm
00840916112608Piranha Cervical Screw Ø 4.25mm x 16mm
00840916112592Piranha Cervical Screw Ø 4.25mm x 14mm
00840916112585Piranha Cervical Screw Ø 4.25mm x 12mm
00840916112578Piranha Cervical Screw Ø 4.0mm x 18mm
00840916112561Piranha Cervical Screw Ø 4.0mm x 16mm
00840916112554Piranha Cervical Screw Ø 4.0mm x 14mm
00840916112547Piranha Cervical Screw Ø 4.0mm x 12mm

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.