| Primary Device ID | B030EZO5020010 |
| NIH Device Record Key | 02639524-e822-4cfe-be6c-11f1028ce386 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enza-O |
| Version Model Number | EZO-502-001 |
| Company DUNS | 054205979 |
| Company Name | CAMBER SPINE TECHNOLOGIES, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com | |
| Phone | +1(484) 427-7060 |
| quality@cambermedtech.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B030EZO5020010 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[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
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-26 |
| Device Publish Date | 2024-07-18 |
| 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 |