Zodiac
TI 6.5MM Cannulated High TOP Polyaxial Screw ASM, 45MM Long
13manufacturers in China registered for this device type
401catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K100685 |
| Record published | 2015-08-31 |
| 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 4 to 8.5 mm; length 8.5 to 600 mm; angle 15 to 30 °; height 10 to 85 mm; length 50 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 22175-40 | Length 40 mm | In distribution |
| 82145-40 | Outer Diameter 4.5 mm | In distribution |
| 82075-45 | Length 45 mm | In distribution |
| 62150-40 | Outer Diameter 5 mm | In distribution |
| 82275-45 | Length 45 mm | In distribution |
| 62017-40-30 | Angle 30 ° | In distribution |
| 62075-45 | Outer Diameter 7.5 mm | In distribution |
| 22175-95 | Outer Diameter 7.5 mm | In distribution |
| 62004-12 | Outer Diameter 5.5 mm | In distribution |
| 22165-40 | Length 40 mm | In distribution |
| 82785-75-15 | Angle 15 ° | In distribution |
| 62285-70 | Length 70 mm | In distribution |
| 42075-50 | Length 50 mm | In distribution |
| 22145-40 | Length 40 mm | In distribution |
| 82145-35 | Outer Diameter 4.5 mm | In distribution |
| 42040-25 | Outer Diameter 4 mm | In distribution |
| 82065-70 | Length 70 mm | In distribution |
| 62555-40 | Length 40 mm | In distribution |
| 82020-50 | Length 50 cm | In distribution |
| 82306 | In distribution | |
| 82785-25-30 | Outer Diameter 8.5 mm | In distribution |
| 42075-40 | Length 40 mm | In distribution |
| 62105-70 | Outer Diameter 5.5 mm | In distribution |
| 82155-55 | Length 55 mm | In distribution |
| 62007 | In distribution | |
| 62040-60 | Outer Diameter 4 mm | In distribution |
| 62017-80-30 | Length 80 mm | In distribution |
| 62320 | In distribution | |
| 62017-80-15 | Outer Diameter 8.5 mm | In distribution |
| 22175-90 | Outer Diameter 7.5 mm | In distribution |
| 42175-95 | Length 95 mm | In distribution |
| 62375-50 | Length 50 mm | In distribution |
| 62765-45 | Outer Diameter 6.5 mm | In distribution |
| 42165-70 | Length 70 mm | In distribution |
| 62008 | In distribution | |
| 82308 | In distribution | |
| 62075-55 | Outer Diameter 7.5 mm | In distribution |
| 62375-80 | Length 80 mm | In distribution |
| 62075-100 | Length 100 mm | In distribution |
| 62245-25 | Outer Diameter 4.5 mm | In distribution |
| 62265-55 | Length 55 mm | In distribution |
| 62265-75 | Length 75 mm | In distribution |
| 62065-25 | Outer Diameter 6.5 mm | In distribution |
| 82050-40 | Length 40 mm | In distribution |
| 62325 | In distribution | |
| 62016-60-15 | Angle 15 ° | In distribution |
| 62175-35 | Length 35 mm | In distribution |
| 62050-35 | Length 35 mm | In distribution |
| 62285-80 | Length 80 mm | In distribution |
| 62175-85 | Outer Diameter 7.5 mm | In distribution |
| 82285-25 | Length 25 mm | In distribution |
| 82775-55-15 | Angle 15 ° | In distribution |
| 82302 | In distribution | |
| 62085-50 | Length 50 mm | In distribution |
| 82055-60 | Outer Diameter 5.5 mm | In distribution |
| 62565-45 | Outer Diameter 6.5 mm | In distribution |
| 22045-40 | Outer Diameter 4.5 mm | In distribution |
| 22075-95 | Length 95 mm | In distribution |
| 62175-40 | Length 40 mm | In distribution |
| 42145-35 | Length 35 mm | In distribution |
| 62575-35 | Length 35 mm | In distribution |
| 82275-75 | Outer Diameter 7.5 mm | In distribution |
| 22155-50 | Length 50 mm | In distribution |
| 62040-45 | Outer Diameter 4 mm | In distribution |
| 82001-50 | Length 50 cm | In distribution |
| 82775-30-30 | Angle 30 ° | In distribution |
| 62004-045 | Length 45 mm | In distribution |
| 62004-095 | Length 95 mm | In distribution |
| 82345-60 | Length 60 mm | In distribution |
| 22165-45 | Length 45 mm | In distribution |
| 62855-40 | Outer Diameter 5.5 mm | In distribution |
| 42075-95 | Length 95 mm | In distribution |
| 62075-40 | Outer Diameter 7.5 mm | In distribution |
| 62085-70 | Outer Diameter 8.5 mm | In distribution |
| 62105-65 | Length 65 mm | In distribution |
| 62105-60 | Length 60 mm | In distribution |
| 62675-50 | Outer Diameter 7.5 mm | In distribution |
| 82971-37 | Outer Diameter 5.5 mm | In distribution |
| 62665-55 | Outer Diameter 6.5 mm | In distribution |
| 82775-45-15 | Length 45 mm | In distribution |
| 62014-11 | Length 110 mm | In distribution |
| 82050-60 | Outer Diameter 5 mm | In distribution |
| 62040-35 | Length 35 mm | In distribution |
| 62365-30 | Length 30 mm | In distribution |
| 62004-08 | Length 80 mm | In distribution |
| 62017-35-15 | Angle 15 ° | In distribution |
| 62065-60 | Length 60 mm | In distribution |
| 22075-75 | Outer Diameter 7.5 mm | In distribution |
| 22065-25 | Outer Diameter 6.5 mm | In distribution |
| 22175-100 | Length 100 mm | In distribution |
| 82311 | In distribution | |
| 82971-75 | Outer Diameter 5.5 mm | In distribution |
| 62001-60 | Length 600 mm | In distribution |
| 62555-45 | Outer Diameter 5.5 mm | In distribution |
| 62755-30 | Outer Diameter 5.5 mm | In distribution |
| 62765-30 | Length 30 mm | In distribution |
| 62575-30 | Length 30 mm | In distribution |
| 62017-60-15 | Angle 15 ° | In distribution |
| 62003-17 | Outer Diameter 5.5 mm | In distribution |
| 62665-60 | Outer Diameter 6.5 mm | In distribution |
| 62165-80 | Outer Diameter 6.5 mm | In distribution |
| 62240-20 | Outer Diameter 4 mm | In distribution |
| 82065-65 | Length 65 mm | In distribution |
| 62004-10 | Length 100 mm | In distribution |
| 62002-30 | Outer Diameter 5.5 mm | In distribution |
| 62155-55 | Outer Diameter 5.5 mm | In distribution |
| 82785-80-30 | Outer Diameter 8.5 mm | In distribution |
| 22065-70 | Length 70 mm | In distribution |
| 22075-35 | Outer Diameter 7.5 mm | In distribution |
| 82785-45-15 | Angle 15 ° | In distribution |
| 62050-40 | Length 40 mm | In distribution |
| 82345-35 | Outer Diameter 4.5 mm | In distribution |
| 82175-40 | Length 40 mm | In distribution |
| 62275-60 | Length 60 mm | In distribution |
| 62317 | In distribution | |
| 22155-55 | Length 55 mm | In distribution |
| 62165-60 | Length 60 mm | In distribution |
| 42155-25 | Length 25 mm | In distribution |
| 62001-20 | Length 200 mm | In distribution |
| 62003-04 | Outer Diameter 5.5 mm | In distribution |
| 62265-30 | Length 30 mm | In distribution |
| 82245-55 | Length 55 mm | In distribution |
| 62065-30 | Length 30 mm | In distribution |
| 62345-30 | Length 30 mm | In distribution |
| 62745-30 | Outer Diameter 4.5 mm | In distribution |
| 62245-35 | Length 35 mm | In distribution |
| 42175-30 | Outer Diameter 7.5 mm | In distribution |
| 42175-25 | Outer Diameter 7.5 mm | In distribution |
| 42065-55 | Outer Diameter 6.5 mm | In distribution |
| 62016-30-15 | Length 30 mm | In distribution |
| 82045-25 | Length 25 mm | In distribution |
| 82785-35-30 | Length 35 mm | In distribution |
| 62150-35 | Length 35 mm | In distribution |
| 62075-30 | Outer Diameter 7.5 mm | In distribution |
| 62004-065 | Outer Diameter 5.5 mm | In distribution |
| 62017-60-30 | Outer Diameter 8.5 mm | In distribution |
| 62004-15 | Outer Diameter 5.5 mm | In distribution |
| 62745-55 | Outer Diameter 4.5 mm | In distribution |
| 22065-50 | Length 50 mm | In distribution |
| 62111-R | In distribution | |
| 42065-80 | Length 80 mm | In distribution |
| 62365-25 | Outer Diameter 6.5 mm | In distribution |
| 62155-40 | Length 40 mm | In distribution |
| 62045-45 | Outer Diameter 4.5 mm | In distribution |
| 82365-80 | Outer Diameter 6.5 mm | In distribution |
| 62045-40 | Length 40 mm | In distribution |
| 22175-25 | Length 25 mm | In distribution |
| 62003-13 | Outer Diameter 5.5 mm | In distribution |
| 62014-10 | In distribution | |
| 62265-35 | Length 35 mm | In distribution |
| 82775-55-30 | Angle 30 ° | In distribution |
| 42075-65 | Length 65 mm | In distribution |
| 62085-35 | Outer Diameter 8.5 mm | In distribution |
| 22045-30 | Outer Diameter 4.5 mm | In distribution |
| 42045-35 | Outer Diameter 4.5 mm | In distribution |
| 22040-25 | Length 25 mm | In distribution |
| 62655-35 | Length 35 mm | In distribution |
| 62375-55 | Outer Diameter 7.5 mm | In distribution |
| 82775-35-30 | Angle 30 ° | In distribution |
| 62175-25 | Outer Diameter 7.5 mm | In distribution |
| 62001-45 | Outer Diameter 5.5 mm | In distribution |
| 62155-30 | Length 30 mm | In distribution |
| 22055-45 | Length 45 mm | In distribution |
| 62002-20 | Outer Diameter 5.5 mm | In distribution |
| 82085-70 | Outer Diameter 8.5 mm | In distribution |
| 62145-30 | Outer Diameter 4.5 mm | In distribution |
| 82165-35 | Length 35 mm | In distribution |
| 62245-40 | Outer Diameter 4.5 mm | In distribution |
| 82365-45 | Outer Diameter 6.5 mm | In distribution |
| 42040-40 | Length 40 mm | In distribution |
| 62002-04 | Outer Diameter 5.5 mm | In distribution |
| 22155-30 | Length 30 mm | In distribution |
| 62285-60 | Outer Diameter 8.5 mm | In distribution |
| 62345-35 | Length 35 mm | In distribution |
| 62002-12 | Outer Diameter 5.5 mm | In distribution |
| 82075-65 | Length 65 mm | In distribution |
| 62145-45 | Length 45 mm | In distribution |
| 82775-40-15 | Outer Diameter 7.5 mm | In distribution |
| 82085-80 | Length 80 mm | In distribution |
| 82006-15 | Length 15 mm | In distribution |
| 42040-55 | Outer Diameter 4 mm | In distribution |
| 62575-60 | Outer Diameter 7.5 mm | In distribution |
| 62865-50 | Length 50 mm | In distribution |
| 62555-55 | Outer Diameter 5.5 mm | In distribution |
| 42040-30 | Outer Diameter 4 mm | In distribution |
| 82275-70 | Length 70 mm | In distribution |
| 82001-06 | Outer Diameter 5.5 mm | In distribution |
| 62075-95 | Length 95 mm | In distribution |
| 22145-45 | Length 45 mm | In distribution |
| 42055-25 | Length 25 mm | In distribution |
| 62240-60 | Length 60 mm | In distribution |
| 62745-40 | Length 40 mm | In distribution |
| 82355-30 | Length 30 mm | In distribution |
| 62775-30 | Length 30 mm | In distribution |
| 82240-30 | Outer Diameter 4 mm | In distribution |
| 62285-50 | Outer Diameter 8.5 mm | In distribution |
| 82365-75 | Length 75 mm | In distribution |
| 62319 | Angle 15 ° | In distribution |
| 42045-25 | Length 25 mm | In distribution |
| 62085-55 | Outer Diameter 8.5 mm | In distribution |
| 62001-05 | Length 50 mm | In distribution |
| 82785-60-30 | Angle 30 ° | In distribution |
| 62775-40 | Length 40 mm | In distribution |
| 62075-60 | Outer Diameter 7.5 mm | In distribution |
| 82240-45 | Length 45 mm | In distribution |
| 42075-75 | Outer Diameter 7.5 mm | In distribution |
| 62013 | In distribution | |
| 82355-40 | Length 40 mm | In distribution |
| 62310 | In distribution | |
| 62003-12 | Outer Diameter 5.5 mm | In distribution |
| 62675-30 | Length 30 mm | In distribution |
| 62085-25 | Length 25 mm | In distribution |
| 82165-25 | Outer Diameter 6.5 mm | In distribution |
| 22165-60 | Length 60 mm | In distribution |
| 62375-25 | Outer Diameter 7.5 mm | In distribution |
| 62265-65 | Outer Diameter 6.5 mm | In distribution |
| 62355-35 | Length 35 mm | In distribution |
| 82175-45 | Length 45 mm | In distribution |
| 42065-40 | Length 40 mm | In distribution |
| 22065-60 | Length 60 mm | In distribution |
| 62315 | In distribution | |
| 22175-65 | Length 65 mm | In distribution |
| 22065-65 | Length 65 mm | In distribution |
| 62265-60 | Length 60 mm | In distribution |
| 62017-35-30 | Length 35 mm | In distribution |
| 62150-60 | Outer Diameter 5 mm | In distribution |
| 62175-90 | Outer Diameter 7.5 mm | In distribution |
| 82785-30-15 | Angle 15 ° | In distribution |
| 82275-80 | Outer Diameter 7.5 mm | In distribution |
| 82050-35 | Length 35 mm | In distribution |
| 62155-50 | Length 50 mm | In distribution |
| 22045-60 | Outer Diameter 4.5 mm | In distribution |
| 62265-25 | Outer Diameter 6.5 mm | In distribution |
| 82314 | In distribution | |
| 82275-35 | Length 35 mm | In distribution |
| 62355-60 | Outer Diameter 5.5 mm | In distribution |
| 22065-80 | Outer Diameter 6.5 mm | In distribution |
| 62006-20 | Height 20 mm | In distribution |
| 82075-35 | Length 35 mm | In distribution |
| 82045-45 | Length 45 mm | In distribution |
| 62855-45 | Length 45 mm | In distribution |
| 62001-25 | Outer Diameter 5.5 mm | In distribution |
| 82001-07 | Outer Diameter 5.5 mm | In distribution |
| 62575-55 | Length 55 mm | In distribution |
| 62240-30 | Length 30 mm | In distribution |
| 82355-55 | Length 55 mm | In distribution |
| 42075-90 | Length 90 mm | In distribution |
| 22165-50 | Length 50 mm | In distribution |
| 82155-25 | Outer Diameter 5.5 mm | In distribution |
| 82265-50 | Outer Diameter 6.5 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K090228 | 2009-04-29 |
| K071890 | 2007-11-09 |
| K061321 | 2006-07-07 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2012-09-25 | Class II | Nonconforming Material/Component | The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated Polyaxial Screws, therefore rendering such screws nonfunction | 209 screws | 2013-03-29 |
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.