Savant Lumbar Interbody Fusion System

GUDID B648C31430101580

Titanium PLIF Spacer, 30 x 10 x 15mm, 8 deg

CURITEVA, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device IDB648C31430101580
NIH Device Record Key703c2bf7-6b5f-40de-8054-ea292c015c97
Commercial Distribution StatusIn Commercial Distribution
Brand NameSavant Lumbar Interbody Fusion System
Version Model NumberC314-301015-8
Company DUNS074575332
Company NameCURITEVA, INC.
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

Customer Support Contacts

Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com

Device Dimensions

Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter
Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter
Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter
Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter
Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter
Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter
Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter
Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter
Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter
Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter
Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter
Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter
Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter
Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter
Length30 Millimeter
Angle8 degree
Width10 Millimeter
Height15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB648C31430101580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B648C31430101580]

Moist Heat or Steam Sterilization


[B648C31430101580]

Moist Heat or Steam Sterilization


[B648C31430101580]

Moist Heat or Steam Sterilization


[B648C31430101580]

Moist Heat or Steam Sterilization


[B648C31430101580]

Moist Heat or Steam Sterilization


[B648C31430101580]

Moist Heat or Steam Sterilization


[B648C31430101580]

Moist Heat or Steam Sterilization


[B648C31430101580]

Moist Heat or Steam Sterilization


[B648C31430101580]

Moist Heat or Steam Sterilization


[B648C31430101580]

Moist Heat or Steam Sterilization


[B648C31430101580]

Moist Heat or Steam Sterilization


[B648C31430101580]

Moist Heat or Steam Sterilization


[B648C31430101580]

Moist Heat or Steam Sterilization


[B648C31430101580]

Moist Heat or Steam Sterilization


[B648C31430101580]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-28
Device Publish Date2021-06-20

On-Brand Devices [Savant Lumbar Interbody Fusion System]

B648C40432111600PEEK TLIF Spacer, 32 x 11 x 16mm, 0 deg
B648C40432111500PEEK TLIF Spacer, 32 x 11 x 15mm, 0 deg
B648C40432111400PEEK TLIF Spacer, 32 x 11 x 14mm, 0 deg
B648C40432111300PEEK TLIF Spacer, 32 x 11 x 13mm, 0 deg
B648C40432111200PEEK TLIF Spacer, 32 x 11 x 12mm, 0 deg
B648C40432111100PEEK TLIF Spacer, 32 x 11 x 11mm, 0 deg
B648C40432111000PEEK TLIF Spacer, 32 x 11 x 10mm, 0 deg
B648C40432110900PEEK TLIF Spacer, 32 x 11 x 9mm, 0 deg
B648C40432110800PEEK TLIF Spacer, 32 x 11 x 8mm, 0 deg
B648C40432110700PEEK TLIF Spacer, 32 x 11 x 7mm, 0 deg
B648C40432110600PEEK TLIF Spacer, 32 x 11 x 6mm, 0 deg
B648C40432091600PEEK TLIF Spacer, 32 x 9 x 16mm, 0 deg
B648C40432091500PEEK TLIF Spacer, 32 x 9 x 15mm, 0 deg
B648C40432091400PEEK TLIF Spacer, 32 x 9 x 14mm, 0 deg
B648C40432091300PEEK TLIF Spacer, 32 x 9 x 13mm, 0 deg
B648C40432091200PEEK TLIF Spacer, 32 x 9 x 12mm, 0 deg
B648C40432091100PEEK TLIF Spacer, 32 x 9 x 11mm, 0 deg
B648C40432091000PEEK TLIF Spacer, 32 x 9 x 10mm, 0 deg
B648C40432090900PEEK TLIF Spacer, 32 x 9 x 9mm, 0 deg
B648C40432090800PEEK TLIF Spacer, 32 x 9 x 8mm, 0 deg
B648C40432090700PEEK TLIF Spacer, 32 x 9 x 7mm, 0 deg
B648C40432090600PEEK TLIF Spacer, 32 x 9 x 6mm, 0 deg
B648C40428111600PEEK TLIF Spacer, 28 x 11 x 16mm, 0 deg
B648C40428111500PEEK TLIF Spacer, 28 x 11 x 15mm, 0 deg
B648C40428111400PEEK TLIF Spacer, 28 x 11 x 14mm, 0 deg
B648C40428111300PEEK TLIF Spacer, 28 x 11 x 13mm, 0 deg
B648C40428111200PEEK TLIF Spacer, 28 x 11 x 12mm, 0 deg
B648C40428111100PEEK TLIF Spacer, 28 x 11 x 11mm, 0 deg
B648C40428111000PEEK TLIF Spacer, 28 x 11 x 10mm, 0 deg
B648C40428110900PEEK TLIF Spacer, 28 x 11 x 9mm, 0 deg
B648C40428110800PEEK TLIF Spacer, 28 x 11 x 8mm, 0 deg
B648C40428110700PEEK TLIF Spacer, 28 x 11 x 7mm, 0 deg
B648C40428110600PEEK TLIF Spacer, 28 x 11 x 6mm, 0 deg
B648C40428091600PEEK TLIF Spacer, 28 x 9 x 16mm, 0 deg
B648C40428091500PEEK TLIF Spacer, 28 x 9 x 15mm, 0 deg
B648C40428091400PEEK TLIF Spacer, 28 x 9 x 14mm, 0 deg
B648C40428091300PEEK TLIF Spacer, 28 x 9 x 13mm, 0 deg
B648C40428091200PEEK TLIF Spacer, 28 x 9 x 12mm, 0 deg
B648C40428091100PEEK TLIF Spacer, 28 x 9 x 11mm, 0 deg
B648C40428091000PEEK TLIF Spacer, 28 x 9 x 10mm, 0 deg
B648C40428090900PEEK TLIF Spacer, 28 x 9 x 9mm, 0 deg
B648C40428090800PEEK TLIF Spacer, 28 x 9 x 8mm, 0 deg
B648C40428090700PEEK TLIF Spacer, 28 x 9 x 7mm, 0 deg
B648C40428090600PEEK TLIF Spacer, 28 x 9 x 6mm, 0 deg
B648C30430101680PEEK PLIF Spacer, 30 x 10 x 16mm, 8 deg
B648C30430101600PEEK PLIF Spacer, 30 x 10 x 16mm, 0 deg
B648C30430101580PEEK PLIF Spacer, 30 x 10 x 15mm, 8 deg
B648C30430101500PEEK PLIF Spacer, 30 x 10 x 15mm, 0 deg
B648C30430101480PEEK PLIF Spacer, 30 x 10 x 14mm, 8 deg
B648C30430101400PEEK PLIF Spacer, 30 x 10 x 14mm, 0 deg

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