Ti-Diagon Oblique TLIF

GUDID B030DIT261108180

TLIF Implant, 26mm x 11mm, 18mm, 8° Lordotic

CAMBER SPINE TECHNOLOGIES, LLC

Metallic spinal fusion cage, non-sterile
Primary Device IDB030DIT261108180
NIH Device Record Key92e5706f-87f5-4704-b756-9ae7ac3c9564
Commercial Distribution StatusIn Commercial Distribution
Brand NameTi-Diagon Oblique TLIF
Version Model NumberDIT-2611-0818
Company DUNS054205979
Company NameCAMBER SPINE TECHNOLOGIES, 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB030DIT261108180 [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

[B030DIT261108180]

Moist Heat or Steam Sterilization


[B030DIT261108180]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-05
Device Publish Date2018-04-20

On-Brand Devices [Ti-Diagon Oblique TLIF]

B030DIT281115180TLIF Implant, 28mm x 11mm, 18mm, 15° Lordotic
B030DIT281115170TLIF Implant, 28mm x 11mm, 17mm, 15° Lordotic
B030DIT281115160TLIF Implant, 28mm x 11mm, 16mm, 15° Lordotic
B030DIT281115150TLIF Implant, 28mm x 11mm, 15mm, 15° Lordotic
B030DIT281115140TLIF Implant, 28mm x 11mm, 14mm, 15° Lordotic
B030DIT281115130TLIF Implant, 28mm x 11mm, 13mm, 15° Lordotic
B030DIT281115120TLIF Implant, 28mm x 11mm, 12mm, 15° Lordotic
B030DIT281108180TLIF Implant, 28mm x 11mm, 18mm, 8° Lordotic
B030DIT281108170TLIF Implant, 28mm x 11mm, 17mm, 8° Lordotic
B030DIT281108160TLIF Implant, 28mm x 11mm, 16mm, 8° Lordotic
B030DIT281108150TLIF Implant, 28mm x 11mm, 15mm, 8° Lordotic
B030DIT281108140TLIF Implant, 28mm x 11mm, 14mm, 8° Lordotic
B030DIT281108130TLIF Implant, 28mm x 11mm, 13mm, 8° Lordotic
B030DIT281108120TLIF Implant, 28mm x 11mm, 12mm, 8° Lordotic
B030DIT281108110TLIF Implant, 28mm x 11mm, 11mm, 8° Lordotic
B030DIT281108100TLIF Implant, 28mm x 11mm, 10mm, 8° Lordotic
B030DIT261115180TLIF Implant, 26mm x 11mm, 18mm, 15° Lordotic
B030DIT261115170TLIF Implant, 26mm x 11mm, 17mm, 15° Lordotic
B030DIT261115160TLIF Implant, 26mm x 11mm, 16mm, 15° Lordotic
B030DIT261115150TLIF Implant, 26mm x 11mm, 15mm, 15° Lordotic
B030DIT261115140TLIF Implant, 26mm x 11mm, 14mm, 15° Lordotic
B030DIT261115130TLIF Implant, 26mm x 11mm, 13mm, 15° Lordotic
B030DIT261115120TLIF Implant, 26mm x 11mm, 12mm, 15° Lordotic
B030DIT261115110TLIF Implant, 26mm x 11mm, 11mm, 15° Lordotic
B030DIT261108180TLIF Implant, 26mm x 11mm, 18mm, 8° Lordotic
B030DIT261108170TLIF Implant, 26mm x 11mm, 17mm, 8° Lordotic
B030DIT261108160TLIF Implant, 26mm x 11mm, 16mm, 8° Lordotic
B030DIT261108150TLIF Implant, 26mm x 11mm, 15mm, 8° Lordotic
B030DIT261108140TLIF Implant, 26mm x 11mm, 14mm, 8° Lordotic
B030DIT261108130TLIF Implant, 26mm x 11mm, 13mm, 8° Lordotic
B030DIT261108120TLIF Implant, 26mm x 11mm, 12mm, 8° Lordotic
B030DIT261108110TLIF Implant, 26mm x 11mm, 11mm, 8° Lordotic
B030DIT261108100TLIF Implant, 26mm x 11mm, 10mm, 8° Lordotic
B030DIT261108090TLIF Implant, 26mm x 11mm, 9mm, 8° Lordotic
B030DIT221115180TLIF Implant, 22mm x 11mm, 18mm, 15° Lordotic
B030DIT221115170TLIF Implant, 22mm x 11mm, 17mm, 15° Lordotic
B030DIT221115160TLIF Implant, 22mm x 11mm, 16mm, 15° Lordotic
B030DIT221115150TLIF Implant, 22mm x 11mm, 15mm, 15° Lordotic
B030DIT221115140TLIF Implant, 22mm x 11mm, 14mm, 15° Lordotic
B030DIT221115130TLIF Implant, 22mm x 11mm, 13mm, 15° Lordotic
B030DIT221115120TLIF Implant, 22mm x 11mm, 12mm, 15° Lordotic
B030DIT221115110TLIF Implant, 22mm x 11mm, 11mm, 15° Lordotic
B030DIT221115100TLIF Implant, 22mm x 11mm, 10mm, 15° Lordotic
B030DIT221108180TLIF Implant, 22mm x 11mm, 18mm, 8° Lordotic
B030DIT221108170TLIF Implant, 22mm x 11mm, 17mm, 8° Lordotic
B030DIT221108160TLIF Implant, 22mm x 11mm, 16mm, 8° Lordotic
B030DIT221108150TLIF Implant, 22mm x 11mm, 15mm, 8° Lordotic
B030DIT221108140TLIF Implant, 22mm x 11mm, 14mm, 8° Lordotic
B030DIT221108130TLIF Implant, 22mm x 11mm, 13mm, 8° Lordotic
B030DIT221108120TLIF Implant, 22mm x 11mm, 12mm, 8° Lordotic

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.