Acapella One

GUDID 00840996151962

ACAPELLA,A1 DOUBLE IMPACTOR

Choice Spine, LP

Polymeric spinal interbody fusion cage
Primary Device ID00840996151962
NIH Device Record Key2961f9ce-cd84-4119-83d2-3fd0ebd96a0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcapella One
Version Model Number05-099-02-0000
Company DUNS078293017
Company NameChoice Spine, LP
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 Usefalse
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
GS100840996151962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


[00840996151962]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-04
Device Publish Date2024-02-24

On-Brand Devices [Acapella One]

00840996170291ACAPELLA,TRIAL,RASP,PA,WS,14X16X4
00840996170284ACAPELLA,TRIAL,RASP,PA,WS,12X14X4
00840996170277ACAPELLA,TRIAL,RASP,LR,WS,12X14X4
00840996153263ACAPELLA,INSERTER, INNER WEDGE
00840996153256ACAPELLA,INSERTER
00840996153065ACAPELLA,INSERTER,STANDARD
00840996153058ACAPELLA,INSERTER
00840996153041ACAPELLA,SINGLE IMPACTOR
00840996153034ACAPELLA,SINGLE IMPACTOR
00840996153027ACAPELLA,INSERTER SHAFT V2
00840996153003ACAPELLA,CUP CURETTE 2/0
00840996152990ACAPELLA,FINAL LOCKING TOOL
00840996152983ACAPELLA,MALLET
00840996152976ACAPELLA,CURETTE,ANGLED RING,NRL
00840996152969ACAPELLA,CURETTE,ANGLED RING
00840996152952ACAPELLA,CURETTE,STR RING,NRL
00840996152945ACAPELLA,CURETTE,STRT RING
00840996152938ACAPELLA,DOMED RASP W/ STOP
00840996152921ACAPELLA,DOMED RASP NO STOP
00840996152914ACAPELLA,ANGLE RASP W/S KNURL
00840996152907ACAPELLA,ANGLE RASP N/S KNURL
00840996152891ACAPELLA,ANGLED RASP W/ STOP
00840996152884ACAPELLA,ANGLED RASP NO STOP
00840996152877ACAPELLA,RASP W/S KNURL HNDLE
00840996152860ACAPELLA,RASP N/S KNURL HNDLE
00840996152853ACAPELLA,RASP W/ STOP
00840996152846ACAPELLA,RASP,NO STOP
00840996152839ACAPELLA,A1 ANCHOR REMOVAL
00840996152822ACAPELLA,DISTRACTOR,SM,14X16
00840996152815ACAPELLA,DISTRACTR 14X16
00840996152808ACAPELLA,DISTRACTOR,SM,12X14
00840996152792ACAPELLA,DISTRACTR,12X14
00840996152785ACAPELLA,SHORT DBL IMPACT V2
00840996152778ACAPELLA,SHORT DBL IMPACT V2
00840996152761ACAPELLA,TRIAL,CX,WS,14X18X12
00840996152754ACAPELLA,TRIAL,CX,WS,14X18X11
00840996152747ACAPELLA,TRIAL,CX,WS,14X18X10
00840996152730ACAPELLA,TRIAL,CX,WS,14X18X9
00840996152723ACAPELLA,TRIAL,CX,WS,14X18X8
00840996152716ACAPELLA,TRIAL,CX,WS,14X18X7
00840996152709ACAPELLA,TRIAL,CX,WS,14X18X6
00840996152693ACAPELLA,TRIAL,CX,WS,14X18X5
00840996152686ACAPELLA,TRIAL,CX,WS,14X18X4
00840996152679ACAPELLA,TRIAL,CX,WS,14X16X12
00840996152662ACAPELLA,TRIAL,CX,WS,14X16X11
00840996152655ACAPELLA,TRIAL,DM,WS,14X16X10
00840996152648ACAPELLA,TRIAL,DM,WS,14X16X9
00840996152631ACAPELLA,TRIAL,DM,WS,14X16X8
00840996152624ACAPELLA,TRIAL,DM,WS,14X16X7
00840996152617ACAPELLA,TRIAL,DM,WS,14X16X6

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