Solanas
POLYAXIAL POSTERIOR SMOOTH SHANK THORACIC SCREW, Ø3.5mm X 48mm
15manufacturers in China registered for this device type
116catalogue numbers in this listing
20510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K191185 |
| Record published | 2014-09-24 |
| Record revised | 2024-09-11 (version 8) |
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 7 to 240 mm; height 3.3 to 6 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 63035-36 | Length 36 mm | In distribution |
| 63135-48 | Length 48 mm | In distribution |
| 63001-110 | Outer Diameter 3.3 mm | In distribution |
| 63001-240 | Outer Diameter 3.3 mm | In distribution |
| 63008 | In distribution | |
| 63021-140 | Length 140 mm | In distribution |
| 75050-016 | Length 16 mm | In distribution |
| 63021-165 | Length 165 mm | In distribution |
| 63040-42 | Outer Diameter 4 mm | In distribution |
| 75045-009 | Outer Diameter 4.5 mm | In distribution |
| 63043-16 | Length 16 mm | In distribution |
| 63001-185 | Length 185 mm | In distribution |
| 63011-210 | Outer Diameter 3.3 mm | In distribution |
| 63021-210 | Length 210 mm | In distribution |
| 63011-035 | Length 35 mm | In distribution |
| 63011-045 | Outer Diameter 3.3 mm | In distribution |
| 63021-215 | Outer Diameter 3.3 mm | In distribution |
| 63011-145 | Length 145 mm | In distribution |
| 63021-145 | Length 145 mm | In distribution |
| 63040-54 | Outer Diameter 4 mm | In distribution |
| 63001-190 | Outer Diameter 3.3 mm | In distribution |
| 63021-080 | Outer Diameter 3.3 mm | In distribution |
| 63001-160 | Outer Diameter 3.3 mm | In distribution |
| 63001-225 | Length 225 mm | In distribution |
| 63040-56 | Length 56 mm | In distribution |
| 63021-115 | Outer Diameter 3.3 mm | In distribution |
| 63001-065 | Outer Diameter 3.3 mm | In distribution |
| 63011-095 | Outer Diameter 3.3 mm | In distribution |
| 63021-205 | Length 205 mm | In distribution |
| 63001-170 | Outer Diameter 3.3 mm | In distribution |
| 63014 | Outer Diameter 3.3 mm | In distribution |
| 63021-160 | Outer Diameter 3.3 mm | In distribution |
| 63135-44 | Length 44 mm | In distribution |
| 75050-010 | Length 10 mm | In distribution |
| 63135-42 | Outer Diameter 3.5 mm | In distribution |
| 63001-075 | Length 75 mm | In distribution |
| 63020 | In distribution | |
| 63011-110 | Length 110 mm | In distribution |
| 63035-28 | Outer Diameter 3.5 mm | In distribution |
| 63011-230 | Outer Diameter 3.3 mm | In distribution |
| 63011-070 | Outer Diameter 3.3 mm | In distribution |
| 63011-195 | Outer Diameter 3.3 mm | In distribution |
| 63001-165 | Outer Diameter 3.3 mm | In distribution |
| 63035-50 | Outer Diameter 3.5 mm | In distribution |
| 75045-015 | Outer Diameter 4.5 mm | In distribution |
| 63021-035 | Outer Diameter 3.3 mm | In distribution |
| 63135-40 | Outer Diameter 3.5 mm | In distribution |
| 63021-105 | Outer Diameter 3.3 mm | In distribution |
| 63035-08 | Length 8 mm | In distribution |
| 63011-215 | Length 215 mm | In distribution |
| 63035-32 | Outer Diameter 3.5 mm | In distribution |
| 63011-055 | Length 55 mm | In distribution |
| 63011-200 | Length 200 mm | In distribution |
| 63011-150 | Outer Diameter 3.3 mm | In distribution |
| 63040-08 | Length 8 mm | In distribution |
| 63040-46 | Outer Diameter 4 mm | In distribution |
| 63021-170 | Outer Diameter 3.3 mm | In distribution |
| 63011-030 | Length 30 mm | In distribution |
| 63040-28 | Outer Diameter 4 mm | In distribution |
| 63021-240 | Outer Diameter 3.3 mm | In distribution |
| 63035-58 | Outer Diameter 3.5 mm | In distribution |
| 63001-210 | Length 210 mm | In distribution |
| 63011-180 | Length 180 mm | In distribution |
| 63011-135 | Outer Diameter 3.3 mm | In distribution |
| 63021-235 | Outer Diameter 3.3 mm | In distribution |
| 63011-185 | Outer Diameter 3.3 mm | In distribution |
| 63021-060 | Outer Diameter 3.3 mm | In distribution |
| 63011-120 | Length 120 mm | In distribution |
| 63035-30 | Length 30 mm | In distribution |
| 63040-36 | Length 36 mm | In distribution |
| 63001-040 | Outer Diameter 3.3 mm | In distribution |
| 63040-22 | Outer Diameter 4 mm | In distribution |
| 63135-38 | Length 38 mm | In distribution |
| 63021-020 | Outer Diameter 3.3 mm | In distribution |
| 63135-36 | Outer Diameter 3.5 mm | In distribution |
| 75050-009 | Outer Diameter 5 mm | In distribution |
| 63011-175 | Length 175 mm | In distribution |
| 63021-135 | Outer Diameter 3.3 mm | In distribution |
| 63001-070 | Length 70 mm | In distribution |
| 63040-14 | Length 14 mm | In distribution |
| 63013 | Height 3.3 mm | In distribution |
| 63021-095 | Outer Diameter 3.3 mm | In distribution |
| 63011-080 | Outer Diameter 3.3 mm | In distribution |
| 63021-175 | Length 175 mm | In distribution |
| 63021-025 | Length 25 mm | In distribution |
| 63021-085 | Outer Diameter 3.3 mm | In distribution |
| 63001-060 | Outer Diameter 3.3 mm | In distribution |
| 63135-60 | Length 60 mm | In distribution |
| 63040-26 | Length 26 mm | In distribution |
| 63012 | Height 6 mm | In distribution |
| 63001-200 | Outer Diameter 3.3 mm | In distribution |
| 63021-195 | Length 195 mm | In distribution |
| 63035-60 | Length 60 mm | In distribution |
| 63135-34 | Length 34 mm | In distribution |
| 63011-165 | Outer Diameter 3.3 mm | In distribution |
| 63001-130 | Length 130 mm | In distribution |
| 75045-007 | Outer Diameter 4.5 mm | In distribution |
| 63003-26 | In distribution | |
| 75050-013 | Length 13 mm | In distribution |
| 75045-008 | Length 8 mm | In distribution |
| 63043-44 | Length 44 mm | In distribution |
| 63011-155 | Length 155 mm | In distribution |
| 63011-115 | Outer Diameter 3.3 mm | In distribution |
| 63021-190 | Length 190 mm | In distribution |
| 63040-34 | Length 34 mm | In distribution |
| 63010 | In distribution | |
| 75050-012 | Length 12 mm | In distribution |
| 63001-095 | Length 95 mm | In distribution |
| 63135-46 | Length 46 mm | In distribution |
| 63043-28 | Outer Diameter 4.35 mm | In distribution |
| 63135-20 | Length 20 mm | In distribution |
| 63001-195 | Length 195 mm | In distribution |
| 63001-085 | Outer Diameter 3.3 mm | In distribution |
| 63021-200 | Outer Diameter 3.3 mm | In distribution |
| 75025 | In distribution | |
| 63001-135 | Length 135 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261284 | 2026-07-14 |
| K241519 | 2024-06-21 |
| K232275 | 2023-09-27 |
| K214006 | 2022-04-04 |
| K213460 | 2021-12-10 |
| K203056 | 2020-11-23 |
| K202327 | 2020-10-15 |
| K192938 | 2019-12-12 |
| K181980 | 2018-09-25 |
| K181677 | 2018-08-09 |
| K173522 | 2017-11-30 |
| K161363 | 2016-06-10 |
| K152968 | 2015-12-30 |
| K143149 | 2015-01-05 |
| K133221 | 2014-03-13 |
| K131119 | 2013-05-21 |
| K123623 | 2013-02-14 |
| K111634 | 2012-01-25 |
| K111076 | 2011-07-12 |
| K071380 | 2007-08-20 |
Recalls
5 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 |
|---|---|---|---|---|---|
| 2017-05-05 | Class II | Under Investigation by firm | Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body. | 16,959 units | 2017-06-06 |
| 2016-10-05 | Class II | Under Investigation by firm | Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body. | 16,972 units | 2017-02-17 |
| 2014-06-26 | Class II | Unknown/Undetermined by firm | Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use. | 14 units total (12 units in US) | 2014-09-03 |
| 2013-06-28 | Class II | Equipment maintenance | The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mat | 333 screws | 2014-10-09 |
| 2013-05-06 | Class II | Device Design | Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia” Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this cond | 1,814 | 2014-09-25 |
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.