Enza-O NA

GUDID B030EZO263208090

ENZA®-O 26mm x 32mm, 8° Lordotic, 9mm

CAMBER SPINE TECHNOLOGIES, LLC

Metallic spinal interbody fusion cage

Primary Device ID	B030EZO263208090
NIH Device Record Key	cee8e23b-ebc3-45e0-840c-ab25fe85046b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Enza-O
Version Model Number	EZO-2632-0809
Catalog Number	NA
Company DUNS	054205979
Company Name	CAMBER SPINE TECHNOLOGIES, LLC
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(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030EZO263208090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K221324

FDA Product Code

OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

[B030EZO263208090]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-07-24
Device Publish Date	2024-07-16

On-Brand Devices [Enza-O]

B030EZO263215130	ENZA®-O 26mm x 32mm, 15° Lordotic, 13mm
B030EZO303815170	ENZA®-O 30mm x 38mm, 15° Lordotic, 17mm
B030EZO303815150	ENZA®-O 30mm x 38mm, 15° Lordotic, 15mm
B030EZO303815130	ENZA®-O 30mm x 38mm, 15° Lordotic, 13mm
B030EZO303815110	ENZA®-O 30mm x 38mm, 15° Lordotic, 11mm
B030EZO303808170	ENZA®-O 30mm x 38mm, 8° Lordotic, 17mm
B030EZO303808150	ENZA®-O 30mm x 38mm, 8° Lordotic, 15mm
B030EZO303808130	ENZA®-O 30mm x 38mm, 8° Lordotic, 13mm
B030EZO303808110	ENZA®-O 30mm x 38mm, 8° Lordotic, 11mm
B030EZO303808090	ENZA®-O 30mm x 38mm, 8° Lordotic, 9mm
B030EZO263215170	ENZA®-O 26mm x 32mm, 15° Lordotic, 17mm
B030EZO263215150	ENZA®-O 26mm x 32mm, 15° Lordotic, 15mm
B030EZO263215110	ENZA®-O 26mm x 32mm, 15° Lordotic, 11mm
B030EZO263208170	ENZA®-O 26mm x 32mm, 8° Lordotic, 17mm
B030EZO263208150	ENZA®-O 26mm x 32mm, 8° Lordotic, 15mm
B030EZO263208130	ENZA®-O 26mm x 32mm, 8° Lordotic, 13mm
B030EZO263208110	ENZA®-O 26mm x 32mm, 8° Lordotic, 11mm
B030EZO263208090	ENZA®-O 26mm x 32mm, 8° Lordotic, 9mm
B030EZO1020030	ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 13mm
B030EZO1020020	ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 11mm
B030EZO1020010	ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 9mm
B030EZO500002020	Instrument Tray 2
B030EZO500002010	Instrument Tray 1
B030EZO1020140	ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 17mm
B030EZO1020130	ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 15mm
B030EZO1020120	ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 13mm
B030EZO1020110	ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 11mm
B030EZO1020100	ENZA®-O Trial 30mm x 38mm, 8° Lordotic, 9mm
B030EZO1020090	ENZA®-O Trial 26mm x 32mm, 15° Lordotic, 17mm
B030EZO1020080	ENZA®-O Trial 26mm x 32mm, 15° Lordotic, 15mm
B030EZO1020070	ENZA®-O Trial 26mm x 32mm, 15° Lordotic, 13mm
B030EZO1020060	ENZA®-O Trial 26mm x 32mm, 15° Lordotic, 11mm
B030EZO1020050	ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 17mm
B030EZO1020040	ENZA®-O Trial 26mm x 32mm, 8° Lordotic, 15mm
B030EZO5020040	15°, 30mm x 38mm Implant Caddy
B030EZO5020030	15°, 26mm x 32mm Implant Caddy
B030EZO5020020	8°, 30mm x 38mm Implant Caddy
B030EZO5020010	8°, 26mm x 32mm Implant Caddy
B030EZO1032230	Anchor Deployment Ram
B030EZO1031240	T10/AO Locking Driver
B030EZO1020180	ENZA®-O Trial 30mm x 38mm, 15° Lordotic, 17mm
B030EZO1020170	ENZA®-O Trial 30mm x 38mm, 15° Lordotic, 15mm
B030EZO1020160	ENZA®-O Trial 30mm x 38mm, 15° Lordotic, 13mm
B030EZO1020150	ENZA®-O Trial 30mm x 38mm, 15° Lordotic, 11mm
B030EZO5030060	15° Trial Caddy Lid
B030EZO5030050	8° Trial Caddy Lid
B030EZO5030040	15°, 30mm x 38mm Caddy Lid
B030EZO5030030	15°, 26mm x 32mm Caddy Lid
B030EZO5030020	8°, 30mm x 38mm Caddy Lid
B030EZO5030010	8°, 26mm x 32mm Caddy Lid

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