Is this your brand? Sign in to claim ownership.
Sign in to claim this brandACUITY SURGICAL DEVICES, LLC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 8710 N Royal Lane, Irving, TX, 75063
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3010866843
- DUNS Number
- —
Catalogue (766)
Page 16 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Align | 16-22451007 | FDA UDI | Class II | Active |
| Align | 16-22600812 | FDA UDI | Class II | Active |
| A Link Z | 10-000058 | FDA UDI | Class II | Active |
| Align | 11-102550-SP | FDA UDI | Class II | Active |
| Align | 16-22551707-SP | FDA UDI | Class II | Active |
| Align | 14-36261716-SP | FDA UDI | Class II | Active |
| A Link Z | 15-32241012 | FDA UDI | Class II | Active |
| Align | 16-22601512-SP | FDA UDI | Class II | Active |
| Tera Lumbar Interbody Fusion System (Various PNs) | K251335 | FDA 510(k) | Class II | Active |
| Align Cervical Interbody Fusion System | K230639 | FDA 510(k) | Class II | Active |
| Align | K222561 | FDA 510(k) | Class II | Active |
| Align Lumbar Interbody Fusion System | K221535 | FDA 510(k) | Class II | Active |
| sagAlign Lumbar Cage System (Various PNs) | K241413 | FDA 510(k) | Class II | Active |
| Ventris Intervertebral Body Fusion Device | K243386 | FDA 510(k) | Class II | Active |
| Stabilis SA Cervical Stand-Alone System (Various PNs) | K251735 | FDA 510(k) | Class II | Active |
| A-Link Z | K201671 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 7, 2019 | Z-2354-2020 | — | open, classified | Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage. |
| Jan 7, 2019 | Z-2355-2020 | — | open, classified | Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage. |