Solanas
POLYAXIAL POSTERIOR SMOOTH SHANK THORACIC SCREW, Ø3.5mm X 22mm
11manufacturers in China registered for this device type
136catalogue numbers in this listing
4510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K191185 |
| Record published | 2018-01-12 |
| Record revised | 2024-09-11 (version 6) |
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 |
| Sizes | Outer diameter 3.3 to 5 mm; length 8 to 240 mm; height 7 to 8 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 63011-085 | Outer Diameter 3.3 mm | In distribution |
| 63035-26 | Outer Diameter 3.5 mm | In distribution |
| 63021-050 | Length 50 mm | In distribution |
| 75000-066 | In distribution | |
| 63002-420 | In distribution | |
| 63011-160 | Outer Diameter 3.3 mm | In distribution |
| 63040-24 | Length 24 mm | In distribution |
| 63040-50 | Outer Diameter 4 mm | In distribution |
| 63035-42 | Outer Diameter 3.5 mm | In distribution |
| 63135-22 | Outer Diameter 3.5 mm | In distribution |
| 63011-130 | Length 130 mm | In distribution |
| 63040-48 | Outer Diameter 4 mm | In distribution |
| 63040-60 | Outer Diameter 4 mm | In distribution |
| 63035-18 | Length 18 mm | In distribution |
| 63035-20 | Length 20 mm | In distribution |
| 63021-100 | Length 100 mm | In distribution |
| 63011-140 | Length 140 mm | In distribution |
| 63021-055 | Outer Diameter 3.3 mm | In distribution |
| 63001-235 | Outer Diameter 3.3 mm | In distribution |
| 63043-24 | Outer Diameter 4.35 mm | In distribution |
| 63035-44 | Outer Diameter 3.5 mm | In distribution |
| 63001-025 | Length 25 mm | In distribution |
| 63021-075 | Outer Diameter 3.3 mm | In distribution |
| 63021-110 | Length 110 mm | In distribution |
| 63043-40 | Outer Diameter 4.35 mm | In distribution |
| 63035-10 | Outer Diameter 3.5 mm | In distribution |
| 63001-150 | Outer Diameter 3.3 mm | In distribution |
| 63040-38 | Outer Diameter 4 mm | In distribution |
| 63040-18 | Length 18 mm | In distribution |
| 75045-012 | Outer Diameter 4.5 mm | In distribution |
| 63035-16 | Outer Diameter 3.5 mm | In distribution |
| 75045-013 | Outer Diameter 4.5 mm | In distribution |
| 63021-070 | Outer Diameter 3.3 mm | In distribution |
| 63001-230 | Outer Diameter 3.3 mm | In distribution |
| 63001-090 | Outer Diameter 3.3 mm | In distribution |
| 63011-235 | Length 235 mm | In distribution |
| 63035-24 | Length 24 mm | In distribution |
| 63021-230 | Length 230 mm | In distribution |
| 63040-52 | Length 52 mm | In distribution |
| 63040-32 | Length 32 mm | In distribution |
| 63001-030 | Length 30 mm | In distribution |
| 63011-190 | Outer Diameter 3.3 mm | In distribution |
| 63135-26 | Outer Diameter 3.5 mm | In distribution |
| 63011-090 | Length 90 mm | In distribution |
| 63001-055 | Length 55 mm | In distribution |
| 63001-140 | Outer Diameter 3.3 mm | In distribution |
| 63011-105 | Length 105 mm | In distribution |
| 63015 | Outer Diameter 3.3 mm | In distribution |
| 63021-220 | Outer Diameter 3.3 mm | In distribution |
| 63135-52 | Outer Diameter 3.5 mm | In distribution |
| 63040-20 | Length 20 mm | In distribution |
| 63011-170 | Length 170 mm | In distribution |
| 63035-12 | Length 12 mm | In distribution |
| 63043-20 | Length 20 mm | In distribution |
| 63011-060 | Outer Diameter 3.3 mm | In distribution |
| 63002-500 | In distribution | |
| 63135-58 | Outer Diameter 3.5 mm | In distribution |
| 63011-020 | Length 20 mm | In distribution |
| 63002-320 | In distribution | |
| 63021-150 | Outer Diameter 3.3 mm | In distribution |
| 63035-40 | Outer Diameter 3.5 mm | In distribution |
| 63035-56 | Length 56 mm | In distribution |
| 63040-30 | Outer Diameter 4 mm | In distribution |
| 63035-14 | Length 14 mm | In distribution |
| 63001-180 | Length 180 mm | In distribution |
| 63011-225 | Outer Diameter 3.3 mm | In distribution |
| 63011-240 | Length 240 mm | In distribution |
| 63021-225 | Outer Diameter 3.3 mm | In distribution |
| 63011-040 | Outer Diameter 3.3 mm | In distribution |
| 63001-105 | Outer Diameter 3.3 mm | In distribution |
| 63021-065 | Outer Diameter 3.3 mm | In distribution |
| 63040-16 | Length 16 mm | In distribution |
| 75050-008 | Outer Diameter 5 mm | In distribution |
| 63043-36 | Outer Diameter 4.35 mm | In distribution |
| 63003-37 | In distribution | |
| 63035-52 | Outer Diameter 3.5 mm | In distribution |
| 63001-205 | Outer Diameter 3.3 mm | In distribution |
| 63135-24 | Length 24 mm | In distribution |
| 63001-220 | Length 220 mm | In distribution |
| 63021-125 | Outer Diameter 3.3 mm | In distribution |
| 63035-38 | Outer Diameter 3.5 mm | In distribution |
| 63021-180 | Length 180 mm | In distribution |
| 63035-54 | Length 54 mm | In distribution |
| 63135-54 | Length 54 mm | In distribution |
| 63001-035 | Length 35 mm | In distribution |
| 63011 | In distribution | |
| 63001-080 | Outer Diameter 3.3 mm | In distribution |
| 63011-050 | Outer Diameter 3.3 mm | In distribution |
| 63135-28 | Length 28 mm | In distribution |
| 75050-011 | Outer Diameter 5 mm | In distribution |
| 63040-12 | Outer Diameter 4 mm | In distribution |
| 63035-46 | Length 46 mm | In distribution |
| 63021-030 | Outer Diameter 3.3 mm | In distribution |
| 63001-175 | Length 175 mm | In distribution |
| 63011-075 | Outer Diameter 3.3 mm | In distribution |
| 63001-155 | Length 155 mm | In distribution |
| 63135-30 | Outer Diameter 3.5 mm | In distribution |
| 63035-48 | Outer Diameter 3.5 mm | In distribution |
| 63021-185 | Outer Diameter 3.3 mm | In distribution |
| 63011-025 | Length 25 mm | In distribution |
| 75045-010 | Outer Diameter 4.5 mm | In distribution |
| 63021 | Height 7 mm | In distribution |
| 63040-10 | Length 10 mm | In distribution |
| 63021-045 | Length 45 mm | In distribution |
| 63022 | Height 8 mm | In distribution |
| 63040-40 | Outer Diameter 4 mm | In distribution |
| 63009 | In distribution | |
| 63011-065 | Length 65 mm | In distribution |
| 63021-155 | Length 155 mm | In distribution |
| 63011-205 | Length 205 mm | In distribution |
| 63003-60 | In distribution | |
| 63021-130 | Outer Diameter 3.3 mm | In distribution |
| 63001-215 | Length 215 mm | In distribution |
| 63001-115 | Outer Diameter 3.3 mm | In distribution |
| 63040-44 | Outer Diameter 4 mm | In distribution |
| 75045-016 | Outer Diameter 4.5 mm | In distribution |
| 63011-100 | Outer Diameter 3.3 mm | In distribution |
| 63001-020 | Outer Diameter 3.3 mm | In distribution |
| 63135-56 | Length 56 mm | In distribution |
| 63135-50 | Outer Diameter 3.5 mm | In distribution |
| 63021-090 | Length 90 mm | In distribution |
| 75050-015 | Outer Diameter 5 mm | In distribution |
| 63021-040 | Length 40 mm | In distribution |
| 63001-120 | Outer Diameter 3.3 mm | In distribution |
| 63035-22 | Outer Diameter 3.5 mm | In distribution |
| 63001-100 | Length 100 mm | In distribution |
| 63001-050 | Length 50 mm | In distribution |
| 63011-125 | Outer Diameter 3.3 mm | In distribution |
| 63135-32 | Outer Diameter 3.5 mm | In distribution |
| 63001-125 | Outer Diameter 3.3 mm | In distribution |
| 63021-120 | Outer Diameter 3.3 mm | In distribution |
| 63001-045 | Outer Diameter 3.3 mm | In distribution |
| 63001-145 | Outer Diameter 3.3 mm | In distribution |
| 63040-58 | Length 58 mm | In distribution |
| 63035-34 | Length 34 mm | In distribution |
| 63011-220 | Length 220 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103205 | 2011-06-02 |
| K100685 | 2010-06-18 |
| K072081 | 2007-10-24 |
| K052201 | 2005-11-10 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-07-06 | Class II | Process control | The rods were incorrectly laser etched as ILLICO Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length. | 7 | 2013-03-20 |
| 2010-12-09 | Class II | Error in labeling | The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM. | 11 units | 2012-11-09 |
| 2010-11-01 | Not classified | Device Design | These lots were not manufactured correctly in that the instrument does not have the durability required to repeatedly perform over its full service life and, therefore, may experience breakage in the tips. | 27 units | 2012-01-31 |
| 2009-08-05 | Not classified | Process control | Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees. | 163 Units | 2010-06-07 |
| 2009-08-05 | Not classified | Process control | Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees. | 158 units | 2010-06-07 |
| 2008-11-03 | Not classified | Error in labeling | Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated polyaxial screw 6.5 mm x | 56 | 2009-12-08 |
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.