Hinged Laminoplasty
Life Spine Hinged Laminoplasty System uses titanium-alloy plates and screws to hold bone graft in position after laminoplasty. Screw holes at the ends of each plate attach the construct to…
Life Spine Hinged Laminoplasty System uses titanium-alloy plates and screws to hold bone graft in position after laminoplasty. Screw holes at the ends of each plate attach the construct to bone.
A central plate hole permits attachment to autograft or allograft material. The construct buttresses the graft and resists its displacement toward or away from the reconstructed area.
Listed Item
Retaining Laminoplasty Locking Screw, 2.4mm x 11mm
Materials and Scope
The implants are Ti-6Al-4V ELI titanium alloy and are intended for single use. The anatomical indication extends from C3 to T3 after laminoplasty. Components are specified for use within the Life Spine system rather than combined with another manufacturer’s fixation components.
1manufacturer
129catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Life Spine, United States |
|---|---|
| FDA product code | NQW |
| Device type | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K191927 |
| Record published | 2019-11-04 |
| Record revised | 2025-07-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 174-810PM | In distribution | |
| 174-042 | In distribution | |
| 174-910PM | In distribution | |
| 174-810HM | In distribution | |
| 174-2-3007 | In distribution | |
| 174-912HH | In distribution | |
| 174-912MM | In distribution | |
| 174-1708 | In distribution | |
| 174-808MP | In distribution | |
| 174-804HM | In distribution | |
| 174-910PH | In distribution | |
| 174-910MP | In distribution | |
| 174-910PP | In distribution | |
| 114-562-2 | In distribution | |
| 174-1712 | In distribution | |
| 174-305 | In distribution | |
| 174-812MP | In distribution | |
| 174-904MM | In distribution | |
| 174-810MH | In distribution | |
| 174-904PM | In distribution | |
| 174-2-3005 | In distribution | |
| 114-563 | In distribution | |
| 174-904HH | In distribution | |
| 114-562-4 | In distribution | |
| 174-908HH | In distribution | |
| 174-806HP | In distribution | |
| 174-1908 | In distribution | |
| 174-303 | In distribution | |
| 174-912MP | In distribution | |
| 174-812HP | In distribution | |
| 174-810MM | In distribution | |
| 174-906MM | In distribution | |
| 174-908PH | In distribution | |
| 174-308 | In distribution | |
| 174-804HP | In distribution | |
| 174-1000 | In distribution | |
| 174-906MP | In distribution | |
| 174-2-2411 | In distribution | |
| 174-908HM | In distribution | |
| 174-912PP | In distribution | |
| 174-804HH | In distribution | |
| 174-906HP | In distribution | |
| 174-904HM | In distribution | |
| 174-1512 | In distribution | |
| 174-906HH | In distribution | |
| 174-306 | In distribution | |
| 174-910HM | In distribution | |
| 174-808HH | In distribution | |
| 174-812HH | In distribution | |
| 174-810PP | In distribution | |
| 174-910MM | In distribution | |
| 114-562-1 | In distribution | |
| 174-1912 | In distribution | |
| 174-906HM | In distribution | |
| 174-806MH | In distribution | |
| 174-1510 | In distribution | |
| 174-904MH | In distribution | |
| 174-806MM | In distribution | |
| 174-812PM | In distribution | |
| 174-012 | In distribution | |
| 174-912MH | In distribution | |
| 174-1904 | In distribution | |
| 174-906MH | In distribution | |
| 174-806PH | In distribution | |
| 174-908HP | In distribution | |
| 174-908MH | In distribution | |
| 174-808HP | In distribution | |
| 174-304 | In distribution | |
| 174-904HP | In distribution | |
| 174-804PH | In distribution | |
| 174-912PH | In distribution | |
| 114-564 | In distribution | |
| 174-910HP | In distribution | |
| 174-1504 | In distribution | |
| 174-2-3009 | In distribution | |
| 174-808PP | In distribution | |
| 174-013 | In distribution | |
| 174-804PP | In distribution | |
| 174-2-3011 | In distribution | |
| 174-904MP | In distribution | |
| 174-808HM | In distribution | |
| 174-906PH | In distribution | |
| 174-810HH | In distribution | |
| 174-806MP | In distribution | |
| 174-806PP | In distribution | |
| 174-1710 | In distribution | |
| 174-912HM | In distribution | |
| 174-1910 | In distribution | |
| 174-808MM | In distribution | |
| 174-1706 | In distribution | |
| 174-804PM | In distribution | |
| 174-910HH | In distribution | |
| 174-908MM | In distribution | |
| 174-908MP | In distribution | |
| 174-808MH | In distribution | |
| 174-806HH | In distribution | |
| 114-562-3 | In distribution | |
| 174-908PM | In distribution | |
| 174-912HP | In distribution | |
| 174-307 | In distribution | |
| 174-904PH | In distribution | |
| 174-914MH | In distribution | |
| 174-908PP | In distribution | |
| 174-806PM | In distribution | |
| 174-808PM | In distribution | |
| 174-810HP | In distribution | |
| 174-806HM | In distribution | |
| 174-1506 | In distribution | |
| 174-804MH | In distribution | |
| 174-804MP | In distribution | |
| 174-2-2407 | In distribution | |
| 174-906PP | In distribution | |
| 174-812MM | In distribution | |
| 174-812HM | In distribution | |
| 174-810MP | In distribution | |
| 174-2-2405 | In distribution | |
| 174-1508 | In distribution | |
| 174-812MH | In distribution | |
| 174-904PP | In distribution | |
| 174-810PH | In distribution | |
| 174-1704 | In distribution | |
| 174-1906 | In distribution | |
| 174-812PH | In distribution | |
| 174-912PM | In distribution | |
| 174-804MM | In distribution | |
| 174-2-2409 | In distribution | |
| 174-906PM | In distribution | |
| 174-808PH | In distribution | |
| 174-812PP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Xspan Laminoplasty Fixation System | Xtant Medical Holdings, Inc. | 265 |
| Laminoplasty | Seaspine Orthopedics Corporation | 104 |
| Release® Laminoplasty Fixation System | Pioneer Surgical Technology, Inc. | 88 |
| Gallery Laminoplasty System | Biomet Spine | 80 |
| Canopy | Globus Medical, Inc. | 65 |
| Centerpiece™ Plate Fixation System | Medtronic Sofamor Danek, Inc. | 61 |
| Blackbird HLS | Choice Spine, LP | 55 |
| Prowess Laminoplasty System | Curiteva, Inc. | 42 |
| Gallery Laminoplasty Fixation System | Highridge Medical, LLC | 40 |
| Leverage | Nuvasive, Inc. | 38 |
| Relieve | Globus Medical, Inc. | 28 |
| Camber | Nuvasive, Inc. | 27 |
Showing 12 of 19. All products under Orthosis, Spine, Plate, Laminoplasty, Metal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191927 | 2019-09-20 |
| K181717 | 2018-10-12 |
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.