Primary Device ID | B030CG1080120 |
NIH Device Record Key | 938e186d-dc09-404b-aa80-09d82a26a097 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Spira-A |
Version Model Number | CG-108-012 |
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 | B030CG1080120 [Primary] |
HTF | Curette |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B030CG1080120]
Moist Heat or Steam Sterilization
[B030CG1080120]
Moist Heat or Steam Sterilization
[B030CG1080120]
Moist Heat or Steam Sterilization
[B030CG1080120]
Moist Heat or Steam Sterilization
[B030CG1080120]
Moist Heat or Steam Sterilization
[B030CG1080120]
Moist Heat or Steam Sterilization
[B030CG1080120]
Moist Heat or Steam Sterilization
[B030CG1080120]
Moist Heat or Steam Sterilization
[B030CG1080120]
Moist Heat or Steam Sterilization
[B030CG1080120]
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 |