Enza-O

GUDID B030EZO5020010

8°, 26mm x 32mm Implant Caddy

CAMBER SPINE TECHNOLOGIES, LLC

Instrument tray, reusable
Primary Device IDB030EZO5020010
NIH Device Record Key02639524-e822-4cfe-be6c-11f1028ce386
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnza-O
Version Model NumberEZO-502-001
Company DUNS054205979
Company NameCAMBER SPINE TECHNOLOGIES, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB030EZO5020010 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


[B030EZO5020010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-26
Device Publish Date2024-07-18

On-Brand Devices [Enza-O]

B030EZO263215130ENZA®-O 26mm x 32mm, 15° Lordotic, 13mm
B030EZO303815170ENZA®-O 30mm x 38mm, 15° Lordotic, 17mm
B030EZO303815150ENZA®-O 30mm x 38mm, 15° Lordotic, 15mm
B030EZO303815130ENZA®-O 30mm x 38mm, 15° Lordotic, 13mm
B030EZO303815110ENZA®-O 30mm x 38mm, 15° Lordotic, 11mm
B030EZO303808170ENZA®-O 30mm x 38mm, 8° Lordotic, 17mm
B030EZO303808150ENZA®-O 30mm x 38mm, 8° Lordotic, 15mm
B030EZO303808130ENZA®-O 30mm x 38mm, 8° Lordotic, 13mm
B030EZO303808110ENZA®-O 30mm x 38mm, 8° Lordotic, 11mm
B030EZO303808090ENZA®-O 30mm x 38mm, 8° Lordotic, 9mm
B030EZO263215170ENZA®-O 26mm x 32mm, 15° Lordotic, 17mm
B030EZO263215150ENZA®-O 26mm x 32mm, 15° Lordotic, 15mm
B030EZO263215110ENZA®-O 26mm x 32mm, 15° Lordotic, 11mm
B030EZO263208170ENZA®-O 26mm x 32mm, 8° Lordotic, 17mm
B030EZO263208150ENZA®-O 26mm x 32mm, 8° Lordotic, 15mm
B030EZO263208130ENZA®-O 26mm x 32mm, 8° Lordotic, 13mm
B030EZO263208110ENZA®-O 26mm x 32mm, 8° Lordotic, 11mm
B030EZO263208090ENZA®-O 26mm x 32mm, 8° Lordotic, 9mm
B030EZO1020030ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 13mm
B030EZO1020020ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 11mm
B030EZO1020010ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 9mm
B030EZO500002020Instrument Tray 2
B030EZO500002010Instrument Tray 1
B030EZO1020140ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 17mm
B030EZO1020130ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 15mm
B030EZO1020120ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 13mm
B030EZO1020110ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 11mm
B030EZO1020100ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 9mm
B030EZO1020090ENZA®-O Trial 26mm x 32mm, 15° Lordotic, 17mm
B030EZO1020080ENZA®-O Trial 26mm x 32mm, 15° Lordotic, 15mm
B030EZO1020070ENZA®-O Trial 26mm x 32mm, 15° Lordotic, 13mm
B030EZO1020060ENZA®-O Trial 26mm x 32mm, 15° Lordotic, 11mm
B030EZO1020050ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 17mm
B030EZO1020040ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 15mm
B030EZO502004015°, 30mm x 38mm Implant Caddy
B030EZO502003015°, 26mm x 32mm Implant Caddy
B030EZO50200208°, 30mm x 38mm Implant Caddy
B030EZO50200108°, 26mm x 32mm Implant Caddy
B030EZO1032230Anchor Deployment Ram
B030EZO1031240T10/AO Locking Driver
B030EZO1020180ENZA®-O Trial 30mm x 38mm, 15° Lordotic, 17mm
B030EZO1020170ENZA®-O Trial 30mm x 38mm, 15° Lordotic, 15mm
B030EZO1020160ENZA®-O Trial 30mm x 38mm, 15° Lordotic, 13mm
B030EZO1020150ENZA®-O Trial 30mm x 38mm, 15° Lordotic, 11mm
B030EZO503006015° Trial Caddy Lid
B030EZO50300508° Trial Caddy Lid
B030EZO503004015°, 30mm x 38mm Caddy Lid
B030EZO503003015°, 26mm x 32mm Caddy Lid
B030EZO50300208°, 30mm x 38mm Caddy Lid
B030EZO50300108°, 26mm x 32mm Caddy Lid

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