CURE 2.0™ ACP

GUDID B167S11000003500

MEDITECH SPINE, LLC

Spinal fixation plate, non-bioabsorbable
Primary Device IDB167S11000003500
NIH Device Record Keyd75ae1fd-71c8-40ad-9639-9e2490747eb8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCURE 2.0™ ACP
Version Model NumberS1-10-00003-50
Company DUNS182698477
Company NameMEDITECH SPINE, LLC
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB167S11000003500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-18
Device Publish Date2022-02-10

On-Brand Devices [CURE 2.0™ ACP]

B167T21000001100T2-10-00001-10
B167T21000001090T2-10-00001-09
B167T21000001080T2-10-00001-08
B167T21000001070T2-10-00001-07
B167T21000001060T2-10-00001-06
B167T21000001050T2-10-00001-05
B167T1000003620T-10-00003-62
B167T1000003590T-10-00003-59
B167T1000003560T-10-00003-56
B167T1000003530T-10-00003-53
B167T1000003500T-10-00003-50
B167T1000003470T-10-00003-47
B167T1000002460T-10-00002-46
B167T1000002440T-10-00002-44
B167T1000002420T-10-00002-42
B167T1000002400T-10-00002-40
B167T1000002380T-10-00002-38
B167T1000002360T-10-00002-36
B167T1000002340T-10-00002-34
B167T1000002320T-10-00002-32
B167T1000001260T-10-00001-26
B167T1000001240T-10-00001-24
B167T1000001220T-10-00001-22
B167T1000001200T-10-00001-20
B167T1000001180T-10-00001-18
B167T1000001160T-10-00001-16
B167S11000003620S1-10-00003-62
B167S11000003590S1-10-00003-59
B167S11000003560S1-10-00003-56
B167S11000003530S1-10-00003-53
B167S11000003500S1-10-00003-50
B167S11000003470S1-10-00003-47
B167S11000002460S1-10-00002-46
B167S11000002440S1-10-00002-44
B167S11000002420S1-10-00002-42
B167S11000002400S1-10-00002-40
B167S11000002380S1-10-00002-38
B167S11000002360S1-10-00002-36
B167S11000002340S1-10-00002-34
B167S11000002320S1-10-00002-32
B167S11000001260S1-10-00001-26
B167S11000001240S1-10-00001-24
B167S11000001220S1-10-00001-22
B167S11000001200S1-10-00001-20
B167S11000001180S1-10-00001-18
B167S11000001160S1-10-00001-16
B1671000462001000-462-00
B16710004220001000-422-00
B16710004200001000-420-00
B16710004120001000-412-00

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