Release® Laminoplasty Fixation System
LAMINOPLASTY, Ø1.2mm x 8mm DRILL ASSY
1manufacturer
88catalogue numbers in this listing
1510(k) clearance
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 | Pioneer Surgical Technology, Inc., United States |
|---|---|
| FDA product code | NQW |
| Device type | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-03-18 |
| Record revised | 2025-07-02 (version 5) |
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 |
| Distribution end date | 2023-05-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28-SALVGEPLT-18 | Withdrawn | |
| 28-SD-20-12 | Withdrawn | |
| 28-ST-25-14 | Withdrawn | |
| 28-ALLOPLATE-18 | Withdrawn | |
| 28-ST-25-12-C | Withdrawn | |
| 28-STDPLATE-12 | Withdrawn | |
| 28-SD-21-04-C | Withdrawn | |
| 28-SD-20-06 | Withdrawn | |
| 28-SD-20-05 | Withdrawn | |
| 28-STDPLATE-08 | Withdrawn | |
| 28-ST-25-10 | Withdrawn | |
| 725-084 | Ø1.2mm (diameter), 8mm (length) | Withdrawn |
| 28-STDPLATE-06 | Withdrawn | |
| 28-TRIAL-14 | Withdrawn | |
| 28-DRILLSLEEVE | Withdrawn | |
| 28-ST-25-14-C | Withdrawn | |
| 28-SD-21-08-C | Withdrawn | |
| 28-SALVGEPLT-14 | Withdrawn | |
| 28-ST-25-08-C | Withdrawn | |
| 28-CADDY-PLATE-ALL | Withdrawn | |
| 28-MODDRILL-14 | Withdrawn | |
| 28-ALLOPLATE-16 | Withdrawn | |
| 28-DRIVER-C | Withdrawn | |
| 28-DRIVER-C-S | Withdrawn | |
| 28-MODDRILL-12 | Withdrawn | |
| 28-ALLOPLATE-06 | Withdrawn | |
| 28-ALLOPLATE-12 | Withdrawn | |
| 28-ALLOPLATE-08 | Withdrawn | |
| 28-TRIAL-8 | Withdrawn | |
| 28-HOOKBENDER | Withdrawn | |
| 28-FIXEDDRIVER | Withdrawn | |
| 28-INST-TRAY | Withdrawn | |
| 28-CADDY-PLATE-SAL | Withdrawn | |
| 28-ST-25-05 | Withdrawn | |
| 28-SALVGEPLT-16 | Withdrawn | |
| 28-TRIAL-18 | Withdrawn | |
| 28-TRIAL-10 | Withdrawn | |
| 28-CADDY-PLATE-STD | Withdrawn | |
| 28-ST-25-06 | Withdrawn | |
| 28-ST-25-04 | Withdrawn | |
| 28-MODDRIVER | Withdrawn | |
| 28-MODDRILL-4 | Withdrawn | |
| 28-STDPLATE-10 | Withdrawn | |
| 28-SD-20-10 | Withdrawn | |
| 28-LAT-ACSS-HLDR | Withdrawn | |
| 28-ALLOPLATE-14 | Withdrawn | |
| 28-ST-20-12 | Withdrawn | |
| 28-PLATEBENDER | Withdrawn | |
| 28-STDPLATE-14 | Withdrawn | |
| 28-ST-21-08-C | Withdrawn | |
| 28-LAM-ACSS-HLDR | Withdrawn | |
| 28-ST-21-04-C | Withdrawn | |
| 28-ST-25-10-C | Withdrawn | |
| 28-MODDRILL-8 | Withdrawn | |
| 28-CADDY-SCREW-SD | Withdrawn | |
| 28-ST-20-05 | Withdrawn | |
| 28-ST-20-10 | Withdrawn | |
| 28-SD-21-12-C | Withdrawn | |
| 28-ST-20-04 | Withdrawn | |
| 28-ST-21-12-C | Withdrawn | |
| 28-ST-21-10-C | Withdrawn | |
| 28-TRIAL-12 | Withdrawn | |
| 28-SD-21-10-C | Withdrawn | |
| 28-ST-21-05-C | Withdrawn | |
| 28-ALLOPLATE-10 | Withdrawn | |
| 28-ST-25-05-C | Withdrawn | |
| 28-ST-25-12 | Withdrawn | |
| 28-TRIAL-16 | Withdrawn | |
| 28-ST-20-06 | Withdrawn | |
| 28-STDPLATE-18 | Withdrawn | |
| 28-CADDY-SCREW-ST | Withdrawn | |
| 28-SD-20-08 | Withdrawn | |
| 28-ST-25-08 | Withdrawn | |
| 28-TRIAL-6 | Withdrawn | |
| 28-ST-20-08 | Withdrawn | |
| 28-SD-21-05-C | Withdrawn | |
| 28-ST-25-06-C | Withdrawn | |
| 28-MODDRILL-6 | Withdrawn | |
| 28-STDPLATE-16 | Withdrawn | |
| 28-HANDLE | Withdrawn | |
| 28-MODDRILL-10 | Withdrawn | |
| 28-MODDRILL-5 | Withdrawn | |
| 28-IMP-TRAY | Withdrawn | |
| 28-ST-21-06-C | Withdrawn | |
| 28-SD-21-06-C | Withdrawn | |
| 28-ST-25-04-C | Withdrawn | |
| 28-SD-20-04 | Withdrawn | |
| 28-LAM-ELEVATOR | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Xspan Laminoplasty Fixation System | Xtant Medical Holdings, Inc. | 265 |
| Hinged Laminoplasty | Life Spine | 129 |
| Laminoplasty | Seaspine Orthopedics Corporation | 104 |
| 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 |
|---|---|
| K113218 | 2012-01-26 |
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.