IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System
FDA 510(k) clearance K251575 · decided 2025-09-03
Clearance details
- K-number
- K251575
- Device name
- IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System
- Applicant
- Alphatec Spine
- Decision
- Substantially Equivalent
- Date received
- 2025-05-22
- Decision date
- 2025-09-03
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- OVD
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SABER-XA System (K261408) | Elevation Spine | 2026-08-03 |
| Interwedge® Standalone Lateral (K261809) | Foundation Surgical Group | 2026-07-31 |
| Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System (K261353) | Kyocera Medical Technologies, Inc. | 2026-07-15 |
| Anteralign LS coverplate (K260810) | Tyber Medical, LLC | 2026-06-10 |
| MectaLIF 3D Metal Anterior (K254202) | Medacta International S.A. | 2026-05-05 |
| SCRIPT™ Implant System (K253401) | Globus Medical, Inc. | 2026-04-29 |
| Ventana™ A Anterior Lumbar Interbody System (K253559) | Spinal Elements, Inc. | 2026-02-25 |
| DeGen Medical Patient Specific Implant (PSI) System (K251829) | Degen Medical | 2025-12-08 |
| CONDUIT™ SYNFIX™ Evolution Secured Spacer System (K250072) | Avalign Technologies, Inc. | 2025-07-10 |
| ProAM ALIF System (K251644) | Pro Surgical, Inc. | 2025-06-24 |
| Curiteva Porous PEEK Standalone ALIF System (K250845) | Curiteva, Inc. | 2025-06-18 |
| OneLIF™ Interbody Fusion System (K251459) | Novapproach Spine, LLC | 2025-06-12 |
Recalls involving this device
No recalls on record reference this clearance.