Savant Lumbar Interbody Fusion System

GUDID B648C31422101200

Titanium PLIF Spacer, 22 x 10 x 12mm, 0 deg

CURITEVA, INC.

Metallic spinal interbody fusion cage

Primary Device ID	B648C31422101200
NIH Device Record Key	28e3d934-2d24-4e7f-9a95-48b81964b834
Commercial Distribution Status	In Commercial Distribution
Brand Name	Savant Lumbar Interbody Fusion System
Version Model Number	C314-221012-0
Company DUNS	074575332
Company Name	CURITEVA, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter
Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter
Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter
Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter
Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter
Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter
Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter
Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter
Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter
Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter
Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter
Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter
Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter
Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter
Length	22 Millimeter
Angle	0 degree
Width	10 Millimeter
Height	12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B648C31422101200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181589

FDA Product Code

MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[B648C31422101200]

Moist Heat or Steam Sterilization

[B648C31422101200]

Moist Heat or Steam Sterilization

[B648C31422101200]

Moist Heat or Steam Sterilization

[B648C31422101200]

Moist Heat or Steam Sterilization

[B648C31422101200]

Moist Heat or Steam Sterilization

[B648C31422101200]

Moist Heat or Steam Sterilization

[B648C31422101200]

Moist Heat or Steam Sterilization

[B648C31422101200]

Moist Heat or Steam Sterilization

[B648C31422101200]

Moist Heat or Steam Sterilization

[B648C31422101200]

Moist Heat or Steam Sterilization

[B648C31422101200]

Moist Heat or Steam Sterilization

[B648C31422101200]

Moist Heat or Steam Sterilization

[B648C31422101200]

Moist Heat or Steam Sterilization

[B648C31422101200]

Moist Heat or Steam Sterilization

[B648C31422101200]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-06-28
Device Publish Date	2021-06-20

On-Brand Devices [Savant Lumbar Interbody Fusion System]

B648C40432111600	PEEK TLIF Spacer, 32 x 11 x 16mm, 0 deg
B648C40432111500	PEEK TLIF Spacer, 32 x 11 x 15mm, 0 deg
B648C40432111400	PEEK TLIF Spacer, 32 x 11 x 14mm, 0 deg
B648C40432111300	PEEK TLIF Spacer, 32 x 11 x 13mm, 0 deg
B648C40432111200	PEEK TLIF Spacer, 32 x 11 x 12mm, 0 deg
B648C40432111100	PEEK TLIF Spacer, 32 x 11 x 11mm, 0 deg
B648C40432111000	PEEK TLIF Spacer, 32 x 11 x 10mm, 0 deg
B648C40432110900	PEEK TLIF Spacer, 32 x 11 x 9mm, 0 deg
B648C40432110800	PEEK TLIF Spacer, 32 x 11 x 8mm, 0 deg
B648C40432110700	PEEK TLIF Spacer, 32 x 11 x 7mm, 0 deg
B648C40432110600	PEEK TLIF Spacer, 32 x 11 x 6mm, 0 deg
B648C40432091600	PEEK TLIF Spacer, 32 x 9 x 16mm, 0 deg
B648C40432091500	PEEK TLIF Spacer, 32 x 9 x 15mm, 0 deg
B648C40432091400	PEEK TLIF Spacer, 32 x 9 x 14mm, 0 deg
B648C40432091300	PEEK TLIF Spacer, 32 x 9 x 13mm, 0 deg
B648C40432091200	PEEK TLIF Spacer, 32 x 9 x 12mm, 0 deg
B648C40432091100	PEEK TLIF Spacer, 32 x 9 x 11mm, 0 deg
B648C40432091000	PEEK TLIF Spacer, 32 x 9 x 10mm, 0 deg
B648C40432090900	PEEK TLIF Spacer, 32 x 9 x 9mm, 0 deg
B648C40432090800	PEEK TLIF Spacer, 32 x 9 x 8mm, 0 deg
B648C40432090700	PEEK TLIF Spacer, 32 x 9 x 7mm, 0 deg
B648C40432090600	PEEK TLIF Spacer, 32 x 9 x 6mm, 0 deg
B648C40428111600	PEEK TLIF Spacer, 28 x 11 x 16mm, 0 deg
B648C40428111500	PEEK TLIF Spacer, 28 x 11 x 15mm, 0 deg
B648C40428111400	PEEK TLIF Spacer, 28 x 11 x 14mm, 0 deg
B648C40428111300	PEEK TLIF Spacer, 28 x 11 x 13mm, 0 deg
B648C40428111200	PEEK TLIF Spacer, 28 x 11 x 12mm, 0 deg
B648C40428111100	PEEK TLIF Spacer, 28 x 11 x 11mm, 0 deg
B648C40428111000	PEEK TLIF Spacer, 28 x 11 x 10mm, 0 deg
B648C40428110900	PEEK TLIF Spacer, 28 x 11 x 9mm, 0 deg
B648C40428110800	PEEK TLIF Spacer, 28 x 11 x 8mm, 0 deg
B648C40428110700	PEEK TLIF Spacer, 28 x 11 x 7mm, 0 deg
B648C40428110600	PEEK TLIF Spacer, 28 x 11 x 6mm, 0 deg
B648C40428091600	PEEK TLIF Spacer, 28 x 9 x 16mm, 0 deg
B648C40428091500	PEEK TLIF Spacer, 28 x 9 x 15mm, 0 deg
B648C40428091400	PEEK TLIF Spacer, 28 x 9 x 14mm, 0 deg
B648C40428091300	PEEK TLIF Spacer, 28 x 9 x 13mm, 0 deg
B648C40428091200	PEEK TLIF Spacer, 28 x 9 x 12mm, 0 deg
B648C40428091100	PEEK TLIF Spacer, 28 x 9 x 11mm, 0 deg
B648C40428091000	PEEK TLIF Spacer, 28 x 9 x 10mm, 0 deg
B648C40428090900	PEEK TLIF Spacer, 28 x 9 x 9mm, 0 deg
B648C40428090800	PEEK TLIF Spacer, 28 x 9 x 8mm, 0 deg
B648C40428090700	PEEK TLIF Spacer, 28 x 9 x 7mm, 0 deg
B648C40428090600	PEEK TLIF Spacer, 28 x 9 x 6mm, 0 deg
B648C30430101680	PEEK PLIF Spacer, 30 x 10 x 16mm, 8 deg
B648C30430101600	PEEK PLIF Spacer, 30 x 10 x 16mm, 0 deg
B648C30430101580	PEEK PLIF Spacer, 30 x 10 x 15mm, 8 deg
B648C30430101500	PEEK PLIF Spacer, 30 x 10 x 15mm, 0 deg
B648C30430101480	PEEK PLIF Spacer, 30 x 10 x 14mm, 8 deg
B648C30430101400	PEEK PLIF Spacer, 30 x 10 x 14mm, 0 deg

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