CURE LP

GUDID B167S1900061410

MEDITECH SPINE, LLC

Spinal fixation plate, non-bioabsorbable
Primary Device IDB167S1900061410
NIH Device Record Keya8aeb67f-8406-4edd-801a-21aa90b3a5b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCURE LP
Version Model NumberS1-9-00061-41
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
HIBCCB167S1900061410 [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 Date2020-03-23
Device Publish Date2020-03-15

On-Brand Devices [CURE LP]

B167T940141370T-9-40141-37
B167T940141360T-9-40141-36
B167T940141350T-9-40141-35
B167T940141340T-9-40141-34
B167T940141330T-9-40141-33
B167T940141320T-9-40141-32
B167T940141310T-9-40141-31
B167T940141300T-9-40141-30
B167T940141290T-9-40141-29
B167T940051450T-9-40051-45
B167T940051440T-9-40051-44
B167T940051430T-9-40051-43
B167T940051420T-9-40051-42
B167T940051410T-9-40051-41
B167T940051400T-9-40051-40
B167T940051390T-9-40051-39
B167T940051380T-9-40051-38
B167T940051370T-9-40051-37
B167T940051360T-9-40051-36
B167T940051350T-9-40051-35
B167T940051340T-9-40051-34
B167T940051330T-9-40051-33
B167T940041450T-9-40041-45
B167T940041440T-9-40041-44
B167T940041430T-9-40041-43
B167T940041420T-9-40041-42
B167T940041410T-9-40041-41
B167S4942460602S1-9-42460-60
B167S4942460552S1-9-42460-55
B167S2942460501S1-9-42460-50
B167S4942460452S1-9-42460-45
B167S4942460402S1-9-42460-40
B167S2942460351S1-9-42460-35
B167S4942460302S1-9-42460-30
B167S2942460251S1-9-42460-25
B167S4942460202S1-9-42460-20
B167S2942455601S1-9-42455-60
B167S4942455552S1-9-42455-55
B167S2942455501S1-9-42455-50
B167S2942455451S1-9-42455-45
B167S2942455401S1-9-42455-40
B167S2942455351S1-9-42455-35
B167S2942455301S1-9-42455-30
B167S4942455252S1-9-42455-25
B167S2942455201S1-9-42455-20
B167S2942360601S1-9-42360-60
B167S4942360552S1-9-42360-55
B167S2942360501S1-9-42360-50
B167S2942360451S1-9-42360-45
B167S2942360401S1-9-42360-40

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