Endoskeleton® TCS
28 catalogue numbers from 5302-3516, listed by Medtronic Sofamor Danek, Inc., United States, under Intervertebral Fusion Device With Integrated Fixation, Cervical. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
28catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K151596 |
| Record published | 2016-12-15 |
| Record revised | 2024-09-11 (version 11) |
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 3.5 to 3.8 mm; length 13 to 18 mm; height 5 to 11 mm; width 14 to 18 mm; angle 6 °; depth 12 to 16 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5302-3516 | Locking Bone Screw | In distribution |
| 5301-3516 | Standard Bone Screw | In distribution |
| 5302-3513 | 3.5mm Diameter, 13mm Length, No. 8 Hexalobe | In distribution |
| 5366-1410 | 16 x 14 (M/L x A/P) mm | In distribution |
| 5302-3816 | 3.8mm Diameter, 16mm Length, No. 8 Hexalobe | In distribution |
| 5386-1607 | width(MLxAP), 18 x 16, mm | In distribution |
| 5302-3514 | Outer Diameter 3.8 mm | In distribution |
| 5366-1407 | 16 x 14 (M/L x A/P) mm | In distribution |
| 5346-1207 | Depth 12 mm | In distribution |
| 5386-1605 | width(MLxAP), 18 x 16, mm | In distribution |
| 5302-3518 | 3.5mm Diameter, 18mm Length, No. 8 Hexalobe | In distribution |
| 5346-1210 | Lordotic Angle 6 Deg | In distribution |
| 5366-1411 | Height 11 mm | In distribution |
| 5366-1406 | Height 6 mm | In distribution |
| 5301-3513 | Standard Bone Screw | In distribution |
| 5302-3818 | Locking Bone Screw | In distribution |
| 5302-3814 | 3.8mm Diameter, 14mm Length, No. 8 Hexalobe | In distribution |
| 5301-3814 | Standard Bone Screw | In distribution |
| 5386-1611 | Width 18 mm | In distribution |
| 5301-3518 | 3.5mm Diameter, 18mm Length, No. 8 Hexalobe | In distribution |
| 5346-1208 | Height 8 mm | In distribution |
| 5346-1206 | Depth 12 mm | In distribution |
| 5366-1409 | Lordotic Angle 6 Deg | In distribution |
| 5366-1405 | Depth 14 mm | In distribution |
| 5346-1209 | 14 x 12 (M/L x A/P) mm | In distribution |
| 5301-3818 | Outer Diameter 3.5 mm | In distribution |
| 5301-3816 | Outer Diameter 3.5 mm | In distribution |
| 5301-3514 | 3.5mm Diameter, 14mm Length, No. 8 Hexalobe | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113252 | 2012-01-17 |
| K094042 | 2010-06-30 |
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.