Centerpiece™ Plate Fixation System
Screw X0810582 CEN TI Deep Drive 3.0X11
1manufacturer
61catalogue 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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | NQW |
| Device type | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K050082 |
| Record published | 2015-09-01 |
| Record revised | 2025-11-20 (version 7) |
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 |
| Sizes | Width 8 to 18 mm; outer diameter 2.6 to 3 mm; length 4 to 11 mm |
| Distribution end date | 2025-09-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X0810582 | Outer Diameter 3.0 mm | In distribution |
| 853412LH | Width 12.0 mm | In distribution |
| 853-016 | Width 16.0 mm | In distribution |
| 8530408 | Width 8.0 mm | In distribution |
| 853016LH | Width 16.0 mm | In distribution |
| X0810575 | Length 5.0 mm | In distribution |
| X0810577 | Length 9.0 mm | In distribution |
| G8532065 | In distribution | |
| 853-010 | Width 10.0 mm | In distribution |
| 853008LW | Width 8.0 mm | In distribution |
| G8532063 | In distribution | |
| 8532465 | In distribution | |
| 853-014 | Width 14.0 mm | In distribution |
| 853014LH | Width 14.0 mm | In distribution |
| 853016LW | Width 16.0 mm | In distribution |
| 8532063 | In distribution | |
| 8532065 | In distribution | |
| 853018LH | Width 18.0 mm | In distribution |
| G8532465 | In distribution | |
| 8532469 | In distribution | |
| 8532467 | In distribution | |
| 853-418 | Width 18.0 mm | In distribution |
| 853018WM | Width 18.0 mm | In distribution |
| 8532069 | In distribution | |
| 853010LH | Width 10.0 mm | In distribution |
| 853408LH | Width 8.0 mm | In distribution |
| G8532067 | In distribution | |
| 8532067 | In distribution | |
| X0810580 | Length 7.0 mm | In distribution |
| 853018LW | Width 18.0 mm | In distribution |
| 853-018 | Width 18.0 mm | In distribution |
| 853012WM | Width 12.0 mm | In distribution |
| X0810578 | Length 11.0 mm | In distribution |
| 853014WM | Width 14.0 mm | In distribution |
| 853008WM | Width 8.0 mm | In distribution |
| X1006038 | Length 4.0 mm | In distribution |
| 853014LW | Width 14.0 mm | In distribution |
| 853414LH | Width 14.0 mm | In distribution |
| 853-416 | Width 16.0 mm | In distribution |
| 853-412 | Width 12.0 mm | In distribution |
| 8532463 | In distribution | |
| 853012LH | Width 12.0 mm | In distribution |
| X1006037 | Outer Diameter 2.6 mm | In distribution |
| X0810581 | Outer Diameter 3.0 mm | In distribution |
| 853410LH | Width 10.0 mm | In distribution |
| 853010LW | Width 10.0 mm | In distribution |
| 8530000 | In distribution | |
| X0810579 | Length 5.0 mm | In distribution |
| G8532463 | In distribution | |
| 853012LW | Width 12.0 mm | In distribution |
| 8530008 | Width 8.0 mm | In distribution |
| 853-012 | Width 12.0 mm | In distribution |
| 853010WM | Width 10.0 mm | In distribution |
| X0810576 | Length 7.0 mm | In distribution |
| G8532467 | In distribution | |
| G8532469 | In distribution | |
| 853-414 | Width 14.0 mm | In distribution |
| 853016WM | Width 16.0 mm | In distribution |
| 853008LH | Width 8.0 mm | In distribution |
| G8532069 | Withdrawn | |
| 853416LH | Width 16.0 mm | 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 |
| Release® Laminoplasty Fixation System | Pioneer Surgical Technology, Inc. | 88 |
| Gallery Laminoplasty System | Biomet Spine | 80 |
| Canopy | Globus Medical, Inc. | 65 |
| 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 |
|---|---|
| K212428 | 2021-12-13 |
| K050082 | 2005-06-06 |
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.