Laminoplasty
Self Drilling Lamina Screw, Ø3.2mm x 11mm L
1manufacturer
104catalogue numbers in this listing
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 | Seaspine Orthopedics Corporation, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K130830 |
| Record published | 2015-09-24 |
| Record revised | 2025-11-20 (version 7) |
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 | 2016-09-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 52-0110 | 4mm Mouth, 10mm L | In distribution |
| 52-0108 | 4mm Mouth, 8mm L | In distribution |
| 52-1112 | 6mm Mouth, 12mm L | In distribution |
| 52-1208 | 6mm Mouth, 8mm L | In distribution |
| 52-2306 | 6mm | In distribution |
| 52-2108 | 8mm | In distribution |
| 52-1212 | 6mm Mouth, 12mm L | In distribution |
| 52-0308 | 4mm Mouth, 8mm L | In distribution |
| 52-1306 | 6mm Mouth, 6mm L | In distribution |
| 52-3211 | 3.2mm Dia x 11mm L | In distribution |
| 52-1114 | 6mm Mouth, 14mm L | In distribution |
| 52-0401 | 1.5mm | In distribution |
| 52-1314 | 6mm Mouth, 14mm L | In distribution |
| 95-2306 | 6mm L | In distribution |
| 52-0214 | 4mm Mouth, 14mm L | In distribution |
| 52-0310 | 4mm Mouth, 10mm L | In distribution |
| 52-1210 | 6mm Mouth, 10mm L | In distribution |
| 52-0314 | 4mm Mouth, 14mm L | In distribution |
| 52-2705 | 2.7mm Dia x 5mm L | In distribution |
| 52-2206 | 6mm | In distribution |
| 52-2709 | 2.7mm Dia x 9mm L | In distribution |
| 52-0112 | 4mm Mouth, 12mm L | In distribution |
| 52-0210 | 4mm Mouth, 10mm L | In distribution |
| 52-0106 | 4mm Mouth, 6mm L | In distribution |
| 52-2106 | 6mm | In distribution |
| 52-0400 | 1.5mm | In distribution |
| 52-2112 | 12mm | In distribution |
| 52-2208 | 8mm | In distribution |
| 52-0306 | 4mm Mouth, 6mm L | In distribution |
| 95-2316 | 16mm L | In distribution |
| 52-1108 | 6mm Mouth, 8mm L | In distribution |
| 52-0312 | 4mm Mouth, 12mm L | In distribution |
| 52-0208 | 4mm Mouth, 8mm L | In distribution |
| 52-2707 | 2.7mm Dia x 7mm L | In distribution |
| 52-3207 | 3.2mm Dia x 7mm L | In distribution |
| 52-1110 | 6mm Mouth, 10mm L | In distribution |
| 52-2310 | 10mm | In distribution |
| 95-2404 | 4mm L | In distribution |
| 52-2110 | 10mm | In distribution |
| 95-2406 | 6mm L | In distribution |
| 95-2310 | 10mm L | In distribution |
| 52-1310 | 6mm Mouth, 10mm L | In distribution |
| 52-1312 | 6mm Mouth, 12mm L | In distribution |
| 52-0206 | 4mm Mouth, 6mm L | In distribution |
| 52-3209 | 3.2mm Dia x 9mm L | In distribution |
| 95-2314 | 14mm L | In distribution |
| 52-2711 | 2.7mm Dia x 11mm L | In distribution |
| 52-0212 | 4mm Mouth, 12mm L | In distribution |
| 95-2308 | 8mm L | In distribution |
| 52-1308 | 6mm Mouth, 8mm L | In distribution |
| 52-0114 | 4mm Mouth, 14mm L | In distribution |
| 52-2210 | 10mm | In distribution |
| 52-1106 | 6mm Mouth, 6mm L | In distribution |
| 52-0410 | 1.5mm | In distribution |
| 52-1214 | 6mm Mouth, 14mm L | In distribution |
| 52-2212 | 12mm | In distribution |
| 52-1206 | 6mm Mouth, 6mm L | In distribution |
| 95-2312 | 12mm L | In distribution |
| 52-2312 | 12mm | In distribution |
| 52-2308 | 8mm | In distribution |
| 52-3205 | 3.2mm Dia x 5mm L | In distribution |
| 52-1215 | 6mm Mouth, 15mm L | Withdrawn |
| 52-2708 | 2.7mm Dia x 8mm L | Withdrawn |
| 52-0215 | 4mm Mouth, 15mm L | Withdrawn |
| 52-0111 | 4mm Mouth, 11mm L | Withdrawn |
| 52-3206 | 3.2mm Dia x 6mm L | Withdrawn |
| 52-0213 | 4mm Mouth, 13mm L | Withdrawn |
| 52-1315 | 6mm Mouth, 15mm L | Withdrawn |
| 52-1316 | 6mm Mouth, 16mm L | Withdrawn |
| 52-1213 | 6mm Mouth, 13mm L | Withdrawn |
| 52-0211 | 4mm Mouth, 11mm L | Withdrawn |
| 52-1211 | 6mm Mouth, 11mm L | Withdrawn |
| 52-0311 | 4mm Mouth, 11mm L | Withdrawn |
| 52-4000 | Withdrawn | |
| 52-0207 | 4mm Mouth, 7mm L | Withdrawn |
| 52-0116 | 4mm Mouth, 16mm L | Withdrawn |
| 52-2710 | 2.7mm Dia x 10mm L | Withdrawn |
| 52-1216 | 6mm Mouth, 16mm L | Withdrawn |
| 52-1313 | 6mm Mouth, 13mm L | Withdrawn |
| 52-2706 | 2.7mm Dia x 6mm L | Withdrawn |
| 52-0315 | 4mm Mouth, 15mm L | Withdrawn |
| 52-1311 | 6mm Mouth, 11mm L | Withdrawn |
| 52-0113 | 4mm Mouth, 13mm L | Withdrawn |
| 52-1116 | 6mm Mouth, 16mm L | Withdrawn |
| 52-0316 | 4mm Mouth, 16mm L | Withdrawn |
| 52-3210 | 3.2mm Dia x 10mm L | Withdrawn |
| 52-1307 | 6mm Mouth, 7mm L | Withdrawn |
| 52-1115 | 6mm Mouth, 15mm L | Withdrawn |
| 52-0107 | 4mm Mouth, 7mm L | Withdrawn |
| 52-1109 | 6mm Mouth, 9mm L | Withdrawn |
| 52-0309 | 4mm Mouth, 9mm L | Withdrawn |
| 52-0115 | 4mm Mouth, 15mm L | Withdrawn |
| 52-1111 | 6mm Mouth, 11mm L | Withdrawn |
| 52-1309 | 6mm Mouth, 9mm L | Withdrawn |
| 52-3208 | 3.2mm Dia x 8mm L | Withdrawn |
| 52-0109 | 4mm Mouth, 9mm L | Withdrawn |
| 52-0307 | 4mm Mouth, 7mm L | Withdrawn |
| 52-0209 | 4mm Mouth, 9mm L | Withdrawn |
| 52-1107 | 6mm Mouth, 7mm L | Withdrawn |
| 52-0216 | 4mm Mouth, 16mm L | Withdrawn |
| 52-1113 | 6mm Mouth, 13mm L | Withdrawn |
| 52-1207 | 6mm Mouth, 7mm L | Withdrawn |
| 52-1209 | 6mm Mouth, 9mm L | Withdrawn |
| 52-0313 | 4mm Mouth, 13mm L | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Xspan Laminoplasty Fixation System | Xtant Medical Holdings, Inc. | 265 |
| Hinged Laminoplasty | Life Spine | 129 |
| 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
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.