Endoskeleton TCS
Interbody Fusion Device nanoLOCK Surface Technology Parallel Medium 11mm
7manufacturers in China registered for this device type
128catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Titan Spine, LLC, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K142940 |
| Record published | 2015-09-17 |
| Record revised | 2024-09-11 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 5 to 12 mm; depth 12 to 16 mm; width 14 to 18 mm; angle 6 °; outer diameter 3.5 to 3.8 mm; length 13 to 20 mm; length 5 to 21 in; width 2 to 10 in |
| Distribution end date | 2021-03-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5386-1605 | Height 5 mm | Withdrawn |
| 5210-1063 | Withdrawn | |
| 5210-1005 | Length 5 in | Withdrawn |
| 5360-1411-N | Parallel | Withdrawn |
| 5080-1605 | Depth 16 mm | Withdrawn |
| 5340-1205-S | Height 5 mm | Withdrawn |
| 5210-1003 | Width 2 in | Withdrawn |
| 5380-1610 | Height 10 mm | Withdrawn |
| 5040-1207 | Width 14 mm | Withdrawn |
| 5360-1412 | width(MLxAP), 16 x 14, mm | Withdrawn |
| 5380-1607-N | Height 7 mm | Withdrawn |
| 5210-1048 | Length 5 in | Withdrawn |
| 5302-3817 | Locking Bone Screw | Withdrawn |
| 5346-1205-S | Width 14 mm | Withdrawn |
| 5210-1024 | Length 5 in | Withdrawn |
| 5386-1609-N | Lordotic Angle 6 Deg | Withdrawn |
| 5210-1029 | Length 10 in | Withdrawn |
| 5386-1609-S | Height 9 mm | Withdrawn |
| 5340-1209-N | Height 9 mm | Withdrawn |
| 5386-1612-N | Height 12 mm | Withdrawn |
| 5210-1006 | Length 10 in | Withdrawn |
| 5340-1205-N | Parallel | Withdrawn |
| 5210-1064 | Withdrawn | |
| 5360-1410-S | width(MLxAP), 16 x 14, mm | Withdrawn |
| 5380-1611 | Height 11 mm | Withdrawn |
| 5380-1607-S | Height 7 mm | Withdrawn |
| 5301-3817 | Standard Bone Screw | Withdrawn |
| 5360-1409 | width(MLxAP), 16 x 14, mm | Withdrawn |
| 5302-3517 | Outer Diameter 3.8 mm | Withdrawn |
| 5340-1209-S | Parallel | Withdrawn |
| 5380-1612-S | Height 12 mm | Withdrawn |
| 5380-1606 | Depth 16 mm | Withdrawn |
| 5360-1411-S | Parallel | Withdrawn |
| 5360-1407 | Depth 14 mm | Withdrawn |
| 5380-1605 | Height 5 mm | Withdrawn |
| 5301-3520 | 3.5mm Diameter, 20mm Length, No. 8 Hexalobe | Withdrawn |
| 5046-1209 | Height 9 mm | Withdrawn |
| 5302-3520 | Length 20 mm | Withdrawn |
| 5301-3815 | 3.8mm Diameter, 15mm Length, No. 8 Hexalobe | Withdrawn |
| 5386-1611-S | Lordotic Angle 6 Deg | Withdrawn |
| 5340-1210 | Height 10 mm | Withdrawn |
| 5346-1205-N | Lordotic Angle 6 Deg | Withdrawn |
| 5301-3815 | 3.8mm Diameter, 15mm Length, No. 8 Hexalobe | Withdrawn |
| 5302-3515 | Length 15 mm | Withdrawn |
| 5346-1211 | Depth 12 mm | Withdrawn |
| 5366-1407-S | Height 7 mm | Withdrawn |
| 5302-3815 | Outer Diameter 3.8 mm | Withdrawn |
| 5340-1206-N | Height 6 mm | Withdrawn |
| 5340-1207-S | Parallel | Withdrawn |
| 5086-1609 | Lordotic Angle 6 Deg | Withdrawn |
| 5380-1607 | Height 7 mm | Withdrawn |
| 5366-1408-N | Lordotic Angle 6 Deg | Withdrawn |
| 5346-1207 | Height 7 mm | Withdrawn |
| 5386-1607 | Height 7 mm | Withdrawn |
| 5360-1410 | Parallel | Withdrawn |
| 5210-1065 | Withdrawn | |
| 5366-1410-S | Lordotic Angle 6 Deg | Withdrawn |
| 5386-1610-N | Lordotic Angle 6 Deg | Withdrawn |
| 5210-1004 | Length 5 in | Withdrawn |
| 5210-1005 | Length 5 in | Withdrawn |
| 5340-1211-S | Depth 12 mm | Withdrawn |
| 5360-1406-N | Parallel | Withdrawn |
| 5380-1609 | Parallel | Withdrawn |
| 5380-1605-S | Height 5 mm | Withdrawn |
| 5340-1208-N | Parallel | Withdrawn |
| 5386-1606-S | Height 6 mm | Withdrawn |
| 5302-3520 | Locking Bone Screw | Withdrawn |
| 5380-1606 | Height 6 mm | Withdrawn |
| 5340-1207 | Height 7 mm | Withdrawn |
| 5360-1406 | Height 6 mm | Withdrawn |
| 5360-1407-N | Parallel | Withdrawn |
| 5302-3817 | Length 17 mm | Withdrawn |
| 5386-1606-N | Lordotic Angle 6 Deg | Withdrawn |
| 5302-3515 | Outer Diameter 3.8 mm | Withdrawn |
| 5340-1210 | Parallel | Withdrawn |
| 5386-1606 | Lordotic Angle 6 Deg | Withdrawn |
| 5366-1407 | Height 7 mm | Withdrawn |
| 5380-1609 | Parallel | Withdrawn |
| 5360-1405 | width(MLxAP), 16 x 14, mm | Withdrawn |
| 5340-1211-N | Parallel | Withdrawn |
| 5380-1605-N | Height 5 mm | Withdrawn |
| 5340-1207-N | width(MLxAP), 14 x 12, mm | Withdrawn |
| 5210-1021 | Length 9 in | Withdrawn |
| 5360-1409-N | Parallel | Withdrawn |
| 5040-1205 | Width 14 mm | Withdrawn |
| 5386-1611 | Lordotic Angle 6 Deg | Withdrawn |
| 5301-3519 | Length 19 mm | Withdrawn |
| 5066-1405 | Height 5 mm | Withdrawn |
| 5340-1212-N | Height 12 mm | Withdrawn |
| 5302-3513 | Length 13 mm | Withdrawn |
| 5301-3516 | Outer Diameter 3.5 mm | Withdrawn |
| 5910-1001 | Width 10 in | Withdrawn |
| 5380-1608 | Height 8 mm | Withdrawn |
| 5380-1610 | Parallel | Withdrawn |
| 5046-1207 | Lordotic Angle 6 Deg | Withdrawn |
| 5360-1405-N | Height 5 mm | Withdrawn |
| 5302-3820 | Length 20 mm | Withdrawn |
| 5301-3520 | Length 20 mm | Withdrawn |
| 5302-3813 | Outer Diameter 3.8 mm | Withdrawn |
| 5366-1412 | Lordotic Angle 6 Deg | Withdrawn |
| 5366-1405-S | Height 5 mm | Withdrawn |
| 5346-1206-N | Height 6 mm | Withdrawn |
| 5340-1208-S | Height 8 mm | Withdrawn |
| 5360-1408-S | Parallel | Withdrawn |
| 5360-1410-N | Parallel | Withdrawn |
| 5360-1405 | Height 5 mm | Withdrawn |
| 5340-1210-S | Parallel | Withdrawn |
| 5360-1411 | width(MLxAP), 16 x 14, mm | Withdrawn |
| 5210-1007 | Length 10 in | Withdrawn |
| 5366-1406-S | Height 6 mm | Withdrawn |
| 5360-1407-S | Height 7 mm | Withdrawn |
| 5380-1608 | Height 8 mm | Withdrawn |
| 5366-1411 | Height 11 mm | Withdrawn |
| 5080-1611 | width(MLxAP), 18 x 16, mm | Withdrawn |
| 5386-1605-N | Height 5 mm | Withdrawn |
| 5340-1207 | Height 7 mm | Withdrawn |
| 5340-1208 | Parallel | Withdrawn |
| 5086-1607 | Height 7 mm | Withdrawn |
| 5366-1405-N | Lordotic Angle 6 Deg | Withdrawn |
| 5301-3519 | Standard Bone Screw | Withdrawn |
| 5210-1045 | Length 10 in | Withdrawn |
| 5080-1609 | Width 18 mm | Withdrawn |
| 5380-1606-S | Parallel | Withdrawn |
| 5301-3517 | Length 17 mm | Withdrawn |
| 5366-1405 | Height 5 mm | Withdrawn |
| 5301-3813 | Length 13 mm | Withdrawn |
| 5346-1208-S | Lordotic Angle 6 Deg | Withdrawn |
| 5346-1206 | Height 6 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192018 | 2019-08-16 |
| K183557 | 2019-02-11 |
| K173535 | 2018-02-13 |
| K100889 | 2010-07-29 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2021-09-02 | Class II | Packaging change control | Engraving on implants may not match what is listed on the pouch labels. | 9 units | 2023-10-05 |
| Titan Spine, LLC | 510(k) number | 2015-07-20 | Class II | Nonconforming Material/Component | Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not ‘locking’. | 137 units | 2015-10-20 |
| Titan Spine, LLC | 510(k) number | 2015-02-20 | Class II | Nonconforming Material/Component | The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6 Drive | 26 | 2015-04-17 |
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.