Ventana C

GUDID 00840606181839

CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP4MM/6MM RASP

SPINAL ELEMENTS, INC.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID00840606181839
NIH Device Record Key8315f29b-ac96-4f96-ae38-ec8eff3d4a2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameVentana C
Version Model Number40021-701
Company DUNS610712213
Company NameSPINAL ELEMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100840606181839 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


[00840606181839]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-05
Device Publish Date2023-08-28

On-Brand Devices [Ventana C]

00840606175791Ventana™ C 14mm x 11mm 7° Caddy Assembly
00840606181860CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP15MM/12MM RASP
00840606181853CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP9MM/10MM RASP
00840606181846CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP7MM/8MM RASP
00840606181839CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP4MM/6MM RASP
00840606181822CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP15MM/12MM
00840606181815CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP9MM/10MM
00840606181808CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP7MM/8MM
00840606181792CERVICAL 20MM X 16MM, 7° DUAL TRIAL, NO STOP4MM/6MM
00840606181785CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP15MM/12MM RASP
00840606181778CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP9MM/10MM RASP
00840606181761CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP7MM/8MM RASP
00840606181754CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP 4MM/6MM RASP
00840606181747CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP15MM/12MM
00840606181730CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP9MM/10MM
00840606181723CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP7MM/8MM
00840606181716CERVICAL 18MM X 15MM, 7° DUAL TRIAL, NO STOP4MM/6MM
00840606181587VENTANA™ C CADDY, LID, LARGE
0084060618157020MM X 16MM 12° CADDY, BASE
00840606181563VENTANA™ C 20MM X 16MM 12° CADDY ASSEMBLY
0084060618155616MM X 13MM 12° CADDY, BASE
00840606181549VENTANA™ C 16MM X 13MM 12° CADDY ASSEMBLY
00840606181532VENTANA™ C CADDY, LID, SMALL
0084060618152514MM X 11MM 12° CADDY, BASE
00840606181518VENTANA™ C 14MM X 11MM 12° CADDY ASSEMBLY
00840606181501CERVICAL INSERTER, BODY,LONG SHAFT, LARGE KNOB
00840606181495CERVICAL INSERTER, BODY,MEDIUM SHAFT, LARGE KNOB
00840606181488CERVICAL INSERTER, BODY,SHORT SHAFT, LARGE, KNOB
00840606181471CERVICAL INSERTER, BODY,LONG SHAFT, SMALL KNOB
00840606181464CERVICAL INSERTER, BODY,MEDIUM SHAFT, SMALL KNOB
00840606181457CERVICAL INSERTER, BODY,SHORT SHAFT, SMALL KNOB
00840606181440CERVICAL INSERTER, INTERNAL SHAFT,LONG SHAFT, LARGE KNOB
00840606181433CERVICAL INSERTER, INTERNAL SHAFT,MEDIUM SHAFT, LARGE KNOB
00840606181426CERVICAL INSERTER, INTERNAL SHAFT,SHORT SHAFT, LARGE, KNOB
00840606181419CERVICAL INSERTER, INTERNAL SHAFT,LONG SHAFT, SMALL KNOB
00840606181402CERVICAL INSERTER, INTERNAL SHAFT,MEDIUM SHAFT, SMALL KNOB
00840606181396CERVICAL INSERTER, INTERNAL SHAFT,SHORT SHAFT, SMALL KNOB
0084060618138920MM X 16MM 7° CADDY, BASE
00840606181372VENTANA™ C 20MM X 16MM 7° CADDY ASSEMBLY
0084060618136518MM X 15MM 7° CADDY, BASE
00840606181358VENTANA™ C 18MM X 15MM 7° CADDY ASSEMBLY
0084060618133418MM X 15MM 12° CADDY, BASE
00840606181327VENTANA™ C 18MM X 15MM 12° CADDY ASSEMBLY
0084060618122820MM X 14MM X 12MM 14°VENTANA™ C CERVICAL INTERBODY
0084060618121120MM X 14MM X 11MM 14°VENTANA™ C CERVICAL INTERBODY
0084060618120420MM X 14MM X 10MM 14°VENTANA™ C CERVICAL INTERBODY
0084060618119820MM X 14MM X 9MM 14°VENTANA™ C CERVICAL INTERBODY
0084060618118120MM X 14MM X 8MM 14°VENTANA™ C CERVICAL INTERBODY
0084060618117420MM X 14MM X 7MM 14°VENTANA™ C CERVICAL INTERBODY
0084060618116720MM X 14MM X 12MM 12°VENTANA™ C CERVICAL INTERBODY

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