A8 INTEGR8? Porous Pedicle Screws
Allumin8, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3043234953 | 3043234953 | ALLUMIN8 INC | 1 | N | 2026-01-01 | 3158 W Lakefront Ct Springfield MO US 65810 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850080774205 | A8 INTEGR8® Porous Pedicle Screw System - A8 INTEGR8 INSTRUMENT OUTER CASE, DOUBLE HEIGHT | 417-689-2424 | info@allumin8.com |
| 00850080774212 | A8 INTEGR8® Porous Pedicle Screw System - A8 INTEGR8 INSTRUMENT TRAY, ROD TRAY | 417-689-2424 | info@allumin8.com |
| 00850080774229 | A8 INTEGR8® Porous Pedicle Screw System - A8 INTEGR8 INSTRUMENT TRAY, REDUCERS | 417-689-2424 | info@allumin8.com |
| 00850080774236 | A8 INTEGR8® Porous Pedicle Screw System - Ø5.5mm Titanium Rod Caddy | 417-689-2424 | info@allumin8.com |
| 00850080774243 | A8 INTEGR8® Porous Pedicle Screw System - Ø6.0mm Titanium Rod Caddy | 417-689-2424 | info@allumin8.com |
| 00850080774250 | A8 INTEGR8® Porous Pedicle Screw System - Ø5.5mm CoCr Rod Caddy | 417-689-2424 | info@allumin8.com |
| 00850080774267 | A8 INTEGR8® Porous Pedicle Screw System - Ø6.0mm CoCr Rod Caddy | 417-689-2424 | info@allumin8.com |
| 20850062071012 | A8 INTEGR8® Porous Pedicle Screw System - A8 INTEGR8 Cannulated Fenestrated Porous Pedicle Screw - 1PK, Ø5.5x30mm | 417-689-2424 | info@allumin8.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 348041 | 1476820287 | K242827 | A8 INTEGR8™ Porous Pedicle Screws | NKB | 2025-10-20 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NKB | 1 | 2025-10-20 |
Allumin8, Inc.
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15
2026-05-15