Invictus Bands System
510(k) K253615
Invictus Bands System is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K253615 on 25 Mar 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253615 | Date25 Mar 2026 | StatusActive |
Official records
- FDA 510(k) database K253615
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OWI
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3010
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K253615
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Invictus 14001-S | 14001-S | 00190376696140 | Length 900 mm; Width 3 mm | On the market |
| Invictus 14002-S | 14002-S | 00190376696157 | Length 900 mm; Width 4.25 mm | On the market |
| Invictus 15460 | 15460 | 00190376721699 | — | On the market |
| Invictus 15461 | 15461 | 00190376721705 | — | On the market |
| Invictus 15463 | 15463 | 00190376721712 | — | On the market |
Similar devices
Other devices filed under FDA product code OWI (Bone Fixation Cerclage, Sublaminar).
- Universal Clamp Spinal Fixation System by ZIMMER SPINE, INC.
- Response BandLoc Spinal Fixation by ORTHOPEDIATRICS CORP.
- Nile Alternative Fixation by K2M, INC.
- Spinal Elements Cerclage System by SPINAL ELEMENTS, INC.
- NuVasive VersaTie System by Nu Vasive, Incorporated
- LigaPASS by Medicrea International SA
- JAZZ System by Implanet, S.A.
- JAZZ System, including JAZZ Band by Implanet, S.A.
- NILE Proximal Fixation Spinal System by K2M, INC.
- NAJA™ Ligament Correction System by Cousin Biotech Sas