| Primary Device ID | B030SPL224015080 |
| NIH Device Record Key | 3df27876-18ac-46e9-88da-fb5f319e68ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPIRA-L |
| Version Model Number | SPL-2240-1508 |
| Company DUNS | 054205979 |
| Company Name | CAMBER SPINE TECHNOLOGIES, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| 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 | B030SPL224015080 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B030SPL224015080]
Moist Heat or Steam Sterilization
[B030SPL224015080]
Moist Heat or Steam Sterilization
[B030SPL224015080]
Moist Heat or Steam Sterilization
[B030SPL224015080]
Moist Heat or Steam Sterilization
[B030SPL224015080]
Moist Heat or Steam Sterilization
[B030SPL224015080]
Moist Heat or Steam Sterilization
[B030SPL224015080]
Moist Heat or Steam Sterilization
[B030SPL224015080]
Moist Heat or Steam Sterilization
[B030SPL224015080]
Moist Heat or Steam Sterilization
[B030SPL224015080]
Moist Heat or Steam Sterilization
[B030SPL224015080]
Moist Heat or Steam Sterilization
[B030SPL224015080]
Moist Heat or Steam Sterilization
[B030SPL224015080]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-01 |
| Device Publish Date | 2022-11-23 |
| B031SPL1020020 | Trial, Bi-Convex, Parallel, 18 x 60mm, 10mm |
| B030SPL226015080 | Bi-Convex, 15° Lordotic, 22 x 60mm, 8mm |
| B030SPL225515080 | Bi-Convex, 15° Lordotic, 22 x 55mm, 8mm |
| B030SPL225015080 | Bi-Convex, 15° Lordotic, 22 x 50mm, 8mm |
| B030SPL224515080 | Bi-Convex, 15° Lordotic, 22 x 45mm, 8mm |
| B030SPL224015080 | Bi-Convex, 15° Lordotic, 22 x 40mm, 8mm |
| B030SPL1020380 | Trial, Bi-Convex, 15° Lordotic, 22 x 60mm, 14mm |
| B030SPL1020370 | Trial, Bi-Convex, 15° Lordotic, 22 x 60mm, 12mm |
| B030SPL1020360 | Trial, Bi-Convex, 15° Lordotic, 22 x 60mm, 10mm |
| B030SPL1020350 | Trial, Bi-Convex, 15° Lordotic, 18 x 60mm, 16mm |
| B030SPL1020340 | Trial, Bi-Convex, 15° Lordotic, 18 x 60mm, 14mm |
| B030SPL1020330 | Trial, Bi-Convex, 15° Lordotic, 18 x 60mm, 12mm |
| B030SPL1020320 | Trial, Bi-Convex, 15° Lordotic, 18 x 60mm, 10mm |
| B030SPL1020310 | Trial, Bi-Convex, 15° Lordotic, 18 x 60mm, 8mm |
| B030SPL1020300 | Trial, Bi-Convex, 8° Lordotic, 26 x 60mm, 16mm |
| B030SPL1020290 | Trial, Bi-Convex, 8° Lordotic, 26 x 60mm, 14mm |
| B030SPL1020280 | Trial, Bi-Convex, 8° Lordotic, 26 x 60mm, 12mm |
| B030SPL1020270 | Trial, Bi-Convex, 8° Lordotic, 26 x 60mm, 10mm |
| B030SPL1020260 | Trial, Bi-Convex, 8° Lordotic, 26 x 60mm, 8mm |
| B030SPL1020250 | Trial, Bi-Convex, 8° Lordotic, 22 x 60mm, 16mm |
| B030SPL1020240 | Trial, Bi-Convex, 8° Lordotic, 22 x 60mm, 14mm |
| B030SPL1020230 | Trial, Bi-Convex, 8° Lordotic, 22 x 60mm, 12mm |
| B030SPL1020220 | Trial, Bi-Convex, 8° Lordotic, 22 x 60mm, 10mm |
| B030SPL1020210 | Trial, Bi-Convex, 8° Lordotic, 22 x 60mm, 8mm |
| B030SPL1020200 | Trial, Bi-Convex, 8° Lordotic, 18 x 60mm, 16mm |
| B030SPL1020190 | Trial, Bi-Convex, 8° Lordotic, 18 x 60mm, 14mm |
| B030SPL1020180 | Trial, Bi-Convex, 8° Lordotic, 18 x 60mm, 12mm |
| B030SPL1020170 | Trial, Bi-Convex, 8° Lordotic, 18 x 60mm, 10mm |
| B030SPL1020160 | Trial, Bi-Convex, 8° Lordotic, 18 x 60mm, 8mm |
| B030SPL1020150 | Trial, Bi-Convex, Parallel, 26 x 60mm, 16mm |
| B030SPL1020140 | Trial, Bi-Convex, Parallel, 26 x 60mm, 14mm |
| B030SPL1020130 | Trial, Bi-Convex, Parallel, 26 x 60mm, 12mm |
| B030SPL1020120 | Trial, Bi-Convex, Parallel, 26 x 60mm, 10mm |
| B030SPL1020110 | Trial, Bi-Convex, Parallel, 26 x 60mm, 8mm |
| B030SPL1020100 | Trial, Bi-Convex, Parallel, 22 x 60mm, 16mm |
| B030SPL1020090 | Trial, Bi-Convex, Parallel, 22 x 60mm, 14mm |
| B030SPL1020080 | Trial, Bi-Convex, Parallel, 22 x 60mm, 12mm |
| B030SPL1020070 | Trial, Bi-Convex, Parallel, 22 x 60mm, 10mm |
| B030SPL1020060 | Trial, Bi-Convex, Parallel, 22 x 60mm, 8mm |
| B030SPL1020050 | Trial, Bi-Convex, Parallel, 18 x 60mm, 16mm |
| B030SPL1020040 | Trial, Bi-Convex, Parallel, 18 x 60mm, 14mm |
| B030SPL1020030 | Trial, Bi-Convex, Parallel, 18 x 60mm, 12mm |
| B030SPL1020010 | Trial, Bi-Convex, Parallel, 18 x 60mm, 8mm |
| B030SPL1030010 | Lateral Inserter Handle |
| B030SPL1020520 | Trial, Bi-Convex, Parallel, 18 x 60mm, 6mm |
| B030SPL1020510 | Trial, Bi-Convex, 20° Lordotic, 26 x 60mm, 16mm |
| B030SPL1020500 | Trial, Bi-Convex, 20° Lordotic, 26 x 60mm, 14mm |
| B030SPL1020490 | Trial, Bi-Convex, 20° Lordotic, 22 x 60mm, 16mm |
| B030SPL1020480 | Trial, Bi-Convex, 20° Lordotic, 22 x 60mm, 14mm |
| B030SPL1020470 | Trial, Bi-Convex, 20° Lordotic, 22 x 60mm, 12mm |