| Primary Device ID | B030CG1081100 |
| NIH Device Record Key | e1464e67-0b20-4758-9a60-0483c571401f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spira-A |
| Version Model Number | CG-108-110 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B030CG1081100 [Primary] |
| HTF | Curette |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B030CG1081100]
Moist Heat or Steam Sterilization
[B030CG1081100]
Moist Heat or Steam Sterilization
[B030CG1081100]
Moist Heat or Steam Sterilization
[B030CG1081100]
Moist Heat or Steam Sterilization
[B030CG1081100]
Moist Heat or Steam Sterilization
[B030CG1081100]
Moist Heat or Steam Sterilization
[B030CG1081100]
Moist Heat or Steam Sterilization
[B030CG1081100]
Moist Heat or Steam Sterilization
[B030CG1081100]
Moist Heat or Steam Sterilization
[B030CG1081100]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-27 |
| Device Publish Date | 2025-02-19 |
| B030SPA504080 | Implant Caddy Assembly |
| B030SPA504070 | Implant Caddy Assembly |
| B030SPA504060 | Implant Caddy Assembly |
| B030SPA504050 | Implant Caddy Assembly |
| B030SPA504040 | Implant Caddy Assembly |
| B030SPA504030 | Implant Caddy Assembly |
| B030SPA504020 | Implant Caddy Assembly |
| B030SPA504010 | Implant Caddy Assembly |
| B030SPA502110 | Trial Caddy Assembly |
| B030SPA502100 | Trial Caddy Assembly |
| B030SPA502090 | Trial Caddy Assembly |
| B030SPA500002020 | Bottom Layer |
| B030SPA500002010 | Top Layer |
| B030SPA5000020 | Instrument Tray Assembly, SPIRA Open Matrix ALIF |
| B030SPA500001030 | Bottom Layer |
| B030SPA500001020 | Middle Tray |
| B030SPA500001010 | Top Tray |
| B030SPA5000010 | Implant Case Assembly, SPIRA Open Matrix ALIF |
| B030SPA1023020 | 60° Trial, Bi-Convex 15° Lordotic, 47mm x 18mm, 13mm |
| B030SPA1022060 | 60° Trial, Bi-Convex 20° Lordotic, 29mm x 18mm, 15mm |
| B030SPA1022050 | 60° Trial, Bi-Convex 20° Lordotic, 37mm x 18mm, 15mm |
| B030SPA1022040 | 60° Trial, Bi-Convex 20° Lordotic, 37mm x 18mm, 13mm |
| B030SPA1022030 | 60° Trial, Bi-Convex 15° Lordotic, 37mm x 18mm, 15mm |
| B030SPA1022020 | 60° Trial, Bi-Convex 15° Lordotic, 37mm x 18mm, 13mm |
| B030SPA1022010 | 60° Trial, Bi-Convex 15° Lordotic, 29mm x 18mm, 13mm |
| B030SPA1021080 | 60° Trial, Bi-Convex 20° Lordotic, 26mm x 32mm, 15mm |
| B030SPA1021060 | 60° Trial, Bi-Convex 20° Lordotic, 30mm x 38mm, 15mm |
| B030SPA1021050 | 60° Trial, Bi-Convex 20° Lordotic, 30mm x 38mm, 13mm |
| B030SPA1021040 | 60° Trial, Bi-Convex 15° Lordotic, 30mm x 38mm, 15mm |
| B030SPA1021030 | 60° Trial, Bi-Convex 15° Lordotic, 30mm x 38mm, 13mm |
| B030SPA1021010 | 60° Trial, Bi-Convex 15° Lordotic, 26mm x 32mm, 13mm |
| B030SPA1020410 | Trial, 30 x 38mm, 20° Lordotic, 19mm |
| B030SPA1020400 | Trial, 30 x 38mm, 20° Lordotic, 17mm |
| B030SPA1020390 | Trial, 30 x 38mm, 20° Lordotic, 15mm |
| B030SPA1020380 | Trial, 30 x 38mm, 20° Lordotic, 13mm |
| B030SPA1020350 | Trial, 30 x 38mm, 15° Lordotic, 19mm |
| B030SPA1020340 | Trial, 30 x 38mm, 15° Lordotic, 17mm |
| B030SPA1020330 | Trial, 30 x 38mm, 15° Lordotic, 15mm |
| B030SPA1020320 | Trial, 30 x 38mm, 15° Lordotic, 13mm |
| B030SPA1020310 | Trial, 30 x 38mm, 15° Lordotic, 11mm |
| B030SPA1020290 | Trial, 30 x 38mm, 8° Lordotic, 19mm |
| B030SPA1020280 | Trial, 30 x 38mm, 8° Lordotic, 17mm |
| B030SPA1020270 | Trial, 30 x 38mm, 8° Lordotic, 15mm |
| B030SPA1020260 | Trial, 30 x 38mm, 8° Lordotic, 13mm |
| B030SPA1020250 | Trial, 30 x 38mm, 8° Lordotic, 11mm |
| B030SPA1020240 | Trial, 30 x 38mm, 8° Lordotic, 9mm |
| B030SPA1020230 | Trial, 26 x 32mm, 20° Lordotic, 17mm |
| B030SPA1020220 | Trial, 26 x 32mm, 20° Lordotic, 15mm |
| B030SPA1020210 | Trial, 26 x 32mm, 20° Lordotic, 13mm |
| B030SPA1020200 | Trial, 26 x 32mm, 20° Lordotic, 11mm |