Sage Cervical Interbody Fusion System

GUDID B648C2056360

7 and 8 mm x 7° Trial, 16 x 13mm Footprint

CURITEVA, INC.

Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable
Primary Device IDB648C2056360
NIH Device Record Key6792d47d-1b49-4c08-9035-5f412d1e36ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameSage Cervical Interbody Fusion System
Version Model NumberC205-636
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 Usefalse
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
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com

Device Dimensions

Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter
Height7 Millimeter
Height8 Millimeter
Angle7 degree
Width16 Millimeter
Depth13 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB648C2056360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

[B648C2056360]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-11
Device Publish Date2024-01-03

On-Brand Devices [Sage Cervical Interbody Fusion System]

B648C20418141270PEEK Cervical Spacer, 18 x 14 x 12mm, 7 deg
B648C20418141170PEEK Cervical Spacer, 18 x 14 x 11mm, 7 deg
B648C20418141070PEEK Cervical Spacer, 18 x 14 x 10mm, 7 deg
B648C20418140970PEEK Cervical Spacer, 18 x 14 x 9mm, 7 deg
B648C20418140870PEEK Cervical Spacer, 18 x 14 x 8mm, 7 deg
B648C20418140770PEEK Cervical Spacer, 18 x 14 x 7mm, 7 deg
B648C20418140670PEEK Cervical Spacer, 18 x 14 x 6mm, 7 deg
B648C20418140570PEEK Cervical Spacer, 18 x 14 x 5mm, 7 deg
B648C20414121270PEEK Cervical Spacer, 14 x 12 x 12mm, 7 deg
B648C20414121170PEEK Cervical Spacer, 14 x 12 x 11mm, 7 deg
B648C20414121070PEEK Cervical Spacer, 14 x 12 x 10mm, 7 deg
B648C20414120970PEEK Cervical Spacer, 14 x 12 x 9mm, 7 deg
B648C20414120870PEEK Cervical Spacer, 14 x 12 x 8mm, 7 deg
B648C20414120770PEEK Cervical Spacer, 14 x 12 x 7mm, 7 deg
B648C20414120670PEEK Cervical Spacer, 14 x 12 x 6mm, 7 deg
B648C20414120570PEEK Cervical Spacer, 14 x 12 x 5mm, 7 deg
B648C2241814127CT0PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 12mm, 7 deg
B648C2241814117CT0PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 11mm, 7 deg
B648C2241814107CT0PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 10mm, 7 deg
B648C2241814097CT0PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 9mm, 7 deg
B648C2241814087CT0PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 8mm, 7 deg
B648C2241814077CT0PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 7mm, 7 deg
B648C2241814067CT0PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 6mm, 7 deg
B648C2241814057CT0PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 5mm, 7 deg
B648C2241613127CT0PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 12mm, 7 deg
B648C2241613117CT0PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 11mm, 7 deg
B648C2241613107CT0PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 10mm, 7 deg
B648C2241613097CT0PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 9mm, 7 deg
B648C2241613087CT0PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 8mm, 7 deg
B648C2241613077CT0PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 7mm, 7 deg
B648C2241613067CT0PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 6mm, 7 deg
B648C2241613057CT0PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 5mm, 7 deg
B648C2241412127CT0PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 12mm, 7 deg
B648C2241412117CT0PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 11mm, 7 deg
B648C2241412107CT0PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 10mm, 7 deg
B648C2241412097CT0PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 9mm, 7 deg
B648C2241412087CT0PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 8mm, 7 deg
B648C2241412077CT0PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 7mm, 7 deg
B648C2241412067CT0PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 6mm, 7 deg
B648C2241412057CT0PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 5mm, 7 deg
B648C2241211127CT0PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 12mm, 7 deg
B648C2241211117CT0PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 11mm, 7 deg
B648C2241211107CT0PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 10mm, 7 deg
B648C2241211097CT0PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 9mm, 7 deg
B648C2241211087CT0PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 8mm, 7 deg
B648C2241211077CT0PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 7mm, 7 deg
B648C2241211067CT0PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 6mm, 7 deg
B648C2241211057CT0PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 5mm, 7 deg
B648C21418141270Titanium Cervical Spacer, 18 x 14 x 12mm, 7 deg
B648C21418141170Titanium Cervical Spacer, 18 x 14 x 11mm, 7 deg
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