Macs TL
Macs TL HMA Polyaxial Screw 12X26MM Grey
14manufacturers in China registered for this device type
48catalogue numbers in this listing
11510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2025-11-13 (version 10) |
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 | 2023-08-24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SX792T | Length : 25.000 MM | Withdrawn |
| SX818T | Withdrawn | |
| SX840T | Withdrawn | |
| SX828T | Diameter (mm) : 4.500 MM | Withdrawn |
| SX805T | Length : 26.000 MM | Withdrawn |
| SX826T | Diameter (mm) : 4.500 MM | Withdrawn |
| SX783T | Diameter (mm) : 6.500 MM | Withdrawn |
| SX793T | Length : 30.000 MM | Withdrawn |
| SX810T | Withdrawn | |
| SX835T | Withdrawn | |
| FW320R | Withdrawn | |
| SX801T | Withdrawn | |
| SX829T | Length : 30.000 MM | Withdrawn |
| SX806T | Length : 30.000 MM | Withdrawn |
| SX839T | Withdrawn | |
| SX791T | Diameter (mm) : 7.000 MM | Withdrawn |
| SX832T | Diameter (mm) : 4.000 MM | Withdrawn |
| SX782T | Length : 25.000 MM | Withdrawn |
| SX823T | Length : 40.000 MM | Withdrawn |
| SX785T | Diameter (mm) : 6.500 MM | Withdrawn |
| SX786T | Length : 45.000 MM | Withdrawn |
| SX803T | Withdrawn | |
| SW139T | Length : 34.000 MM | Withdrawn |
| SX784T | Diameter (mm) : 6.500 MM | Withdrawn |
| SX821T | Length : 30.000 MM | Withdrawn |
| SX816T | Withdrawn | |
| SX834T | Withdrawn | |
| SX795T | Length : 40.000 MM | Withdrawn |
| SX814T | Withdrawn | |
| SX841T | Withdrawn | |
| SW140T | Length : 38.000 MM | Withdrawn |
| SW138T | Length : 30.000 MM | Withdrawn |
| SX800T | Withdrawn | |
| SX825T | Withdrawn | |
| SX817T | Withdrawn | |
| SX797T | Diameter (mm) : 7.000 MM | Withdrawn |
| SX813T | Withdrawn | |
| SX796T | Diameter (mm) : 7.000 MM | Withdrawn |
| SX827T | Length : 20.000 MM | Withdrawn |
| SX787T | Diameter (mm) : 6.500 MM | Withdrawn |
| SX812T | Withdrawn | |
| SX811T | Withdrawn | |
| SX807T | Length : 34.000 MM | Withdrawn |
| SX790T | Diameter (mm) : 7.000 MM | Withdrawn |
| SW137T | Length : 26.000 MM | Withdrawn |
| SX802T | Diameter (mm) : 17.000 MM | Withdrawn |
| SX808T | Length : 38.000 MM | Withdrawn |
| SX794T | Diameter (mm) : 7.000 MM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K050813 | 2005-05-04 |
| K050804 | 2005-04-11 |
| K040017 | 2004-05-14 |
| K032059 | 2003-07-25 |
| K011556 | 2001-11-16 |
| K002824 | 2001-05-08 |
| K000486 | 2000-04-14 |
| K974706 | 1998-03-13 |
| K953720 | 1995-11-02 |
| K936269 | 1994-08-15 |
| K913730 | 1992-03-12 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-01-24 | Not classified | Nonconforming Material/Component | The firm has received complaints that the locking ring that sits in the head of the screw can come out of the screw head when engaged with the screwdriver if the screwdriver is improperly angled. | 891 | 2012-12-13 |
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.