Sage Cervical Interbody Fusion System

GUDID B648C2056380

11 and 12 mm x 7° Trial, 16 x 13mm Footprint

CURITEVA, INC.

Surgical implant/trial-implant/sizer holder, reusable

Primary Device ID	B648C2056380
NIH Device Record Key	46fd8abe-fd55-418a-9788-3403d9fddd87
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sage Cervical Interbody Fusion System
Version Model Number	C205-638
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	false
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
Phone	+1 (877) 928-7483
Email	support@curiteva.com
Phone	+1 (877) 928-7483
Email	support@curiteva.com

Device Dimensions

Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter
Height	11 Millimeter
Height	12 Millimeter
Angle	7 degree
Width	16 Millimeter
Depth	13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B648C2056380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181261

FDA Product Code

ODP	Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

[B648C2056380]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-01-11
Device Publish Date	2024-01-03

On-Brand Devices [Sage Cervical Interbody Fusion System]

B648C20418141270	PEEK Cervical Spacer, 18 x 14 x 12mm, 7 deg
B648C20418141170	PEEK Cervical Spacer, 18 x 14 x 11mm, 7 deg
B648C20418141070	PEEK Cervical Spacer, 18 x 14 x 10mm, 7 deg
B648C20418140970	PEEK Cervical Spacer, 18 x 14 x 9mm, 7 deg
B648C20418140870	PEEK Cervical Spacer, 18 x 14 x 8mm, 7 deg
B648C20418140770	PEEK Cervical Spacer, 18 x 14 x 7mm, 7 deg
B648C20418140670	PEEK Cervical Spacer, 18 x 14 x 6mm, 7 deg
B648C20418140570	PEEK Cervical Spacer, 18 x 14 x 5mm, 7 deg
B648C20414121270	PEEK Cervical Spacer, 14 x 12 x 12mm, 7 deg
B648C20414121170	PEEK Cervical Spacer, 14 x 12 x 11mm, 7 deg
B648C20414121070	PEEK Cervical Spacer, 14 x 12 x 10mm, 7 deg
B648C20414120970	PEEK Cervical Spacer, 14 x 12 x 9mm, 7 deg
B648C20414120870	PEEK Cervical Spacer, 14 x 12 x 8mm, 7 deg
B648C20414120770	PEEK Cervical Spacer, 14 x 12 x 7mm, 7 deg
B648C20414120670	PEEK Cervical Spacer, 14 x 12 x 6mm, 7 deg
B648C20414120570	PEEK Cervical Spacer, 14 x 12 x 5mm, 7 deg
B648C2241814127CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 12mm, 7 deg
B648C2241814117CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 11mm, 7 deg
B648C2241814107CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 10mm, 7 deg
B648C2241814097CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 9mm, 7 deg
B648C2241814087CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 8mm, 7 deg
B648C2241814077CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 7mm, 7 deg
B648C2241814067CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 6mm, 7 deg
B648C2241814057CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 5mm, 7 deg
B648C2241613127CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 12mm, 7 deg
B648C2241613117CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 11mm, 7 deg
B648C2241613107CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 10mm, 7 deg
B648C2241613097CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 9mm, 7 deg
B648C2241613087CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 8mm, 7 deg
B648C2241613077CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 7mm, 7 deg
B648C2241613067CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 6mm, 7 deg
B648C2241613057CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 5mm, 7 deg
B648C2241412127CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 12mm, 7 deg
B648C2241412117CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 11mm, 7 deg
B648C2241412107CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 10mm, 7 deg
B648C2241412097CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 9mm, 7 deg
B648C2241412087CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 8mm, 7 deg
B648C2241412077CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 7mm, 7 deg
B648C2241412067CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 6mm, 7 deg
B648C2241412057CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 5mm, 7 deg
B648C2241211127CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 12mm, 7 deg
B648C2241211117CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 11mm, 7 deg
B648C2241211107CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 10mm, 7 deg
B648C2241211097CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 9mm, 7 deg
B648C2241211087CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 8mm, 7 deg
B648C2241211077CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 7mm, 7 deg
B648C2241211067CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 6mm, 7 deg
B648C2241211057CT0	PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 5mm, 7 deg
B648C21418141270	Titanium Cervical Spacer, 18 x 14 x 12mm, 7 deg
B648C21418141170	Titanium Cervical Spacer, 18 x 14 x 11mm, 7 deg

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