Invictus
The Invictus Bands System is a sublaminar fixation and ligament augmentation system made up of bands, sleeves, connectors and set screws. The listed connectors mate with 4.5 to 5.0 mm and…
The Invictus Bands System is a sublaminar fixation and ligament augmentation system made up of bands, sleeves, connectors and set screws.
The listed connectors mate with 4.5 to 5.0 mm and 5.5 to 6.0 mm diameter rods, according to the device description.
Listed Item
Band Side Loading Connector, Perpendicular
System Components
The bands are PET braid with a stainless-steel malleable tip and needle leads at their ends. The leads are detached after insertion and are not intended to be implanted. Sleeves, connectors and set screws are titanium alloy.
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | OWI |
| Device type | Bone Fixation Cerclage, Sublaminar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K253615 |
| Record published | 2026-04-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 900 mm; width 3 to 4.25 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14002-S | Length 900 mm | In distribution |
| 15461 | In distribution | |
| 15460 | In distribution | |
| 14001-S | Length 900 mm | In distribution |
| 15463 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jazz System | Implanet | 118 |
| Hiline | Globus Medical, Inc. | 22 |
| Ligapass | Medicrea International | 20 |
| Translace™ Spinal Tethering System | Medtronic Sofamor Danek, Inc. | 14 |
| Nile™ Alternative Fixation System | VB Spine LLC | 13 |
| Nile™ Proximal Fixation System | VB Spine LLC | 13 |
| Universal Clamp ™ | Zimmer Spine, Inc. | 9 |
| VersaTie | Nuvasive, Inc. | 8 |
| Silc | Globus Medical, Inc. | 8 |
| Mariner Cap | Seaspine Orthopedics Corporation | 7 |
| Jazz Lock | Implanet | 6 |
| Karma | Spinal Elements, Inc. | 3 |
Showing 12 of 20. All products under Bone Fixation Cerclage, Sublaminar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253615 | 2026-03-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.