Endoskeleton® TCS Sterile Barrier System
39 catalogue numbers from 5301-3515-S, listed by Titan Spine, LLC, United States, under Intervertebral Fusion Device With Bone Graft, Cervical. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
39catalogue 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) | K151596 |
| Record published | 2016-12-15 |
| Record revised | 2025-07-14 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Width 14 to 18 mm; depth 12 to 16 mm; height 5 to 12 mm; angle 6 °; outer diameter 3.5 to 3.8 mm; length 13 to 20 mm |
| Distribution end date | 2021-03-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5301-3515-S | Outer Diameter 3.5 mm | In distribution |
| 5366-1410-S | Width 16 mm | Withdrawn |
| 5386-1609-S | Depth 16 mm | Withdrawn |
| 5366-1407-S | width(MLxAP), 16 x 14, mm | Withdrawn |
| 5301-3517-S | Standard Bone Screw | Withdrawn |
| 5386-1608-S | Depth 16 mm | Withdrawn |
| 5302-3520-S | Length 20 mm | Withdrawn |
| 5360-1407-S | Depth 14 mm | Withdrawn |
| 5386-1611-S | Angle 6 ° | Withdrawn |
| 5360-1412-S | Depth 14 mm | Withdrawn |
| 5380-1605-S | width(MLxAP), 18 x 16, mm | Withdrawn |
| 5340-1210-S | Width 14 mm | Withdrawn |
| 5301-3817-S | 3.8mm Diameter, 17mm Length, No. 8 Hexalobe | Withdrawn |
| 5346-1208-S | Width 14 mm | Withdrawn |
| 5302-3517-S | 3.5mm Diameter, 17mm Length, No. 8 Hexalobe | Withdrawn |
| 5386-1605-S | Depth 16 mm | Withdrawn |
| 5386-1607-S | width(MLxAP), 18 x 16, mm | Withdrawn |
| 5301-3520-S | Standard Bone Screw | Withdrawn |
| 5302-3519-S | Outer Diameter 3.8 mm | Withdrawn |
| 5302-3813-S | 3.8mm Diameter, 13mm Length, No. 8 Hexalobe | Withdrawn |
| 5346-1206-S | Angle 6 ° | Withdrawn |
| 5301-3820-S | Outer Diameter 3.5 mm | Withdrawn |
| 5366-1412-S | Depth 14 mm | Withdrawn |
| 5380-1606-S | Width 18 mm | Withdrawn |
| 5302-3817-S | Outer Diameter 3.8 mm | Withdrawn |
| 5301-3815-S | Length 15 mm | Withdrawn |
| 5360-1410-S | Depth 14 mm | Withdrawn |
| 5386-1612-S | width(MLxAP), 18 x 16, mm | Withdrawn |
| 5380-1607-S | Depth 16 mm | Withdrawn |
| 5302-3820-S | Locking Bone Screw | Withdrawn |
| 5346-1209-S | Angle 6 ° | Withdrawn |
| 5340-1206-S | width(MLxAP), 14 x 12, mm | Withdrawn |
| 5340-1209-S | Width 14 mm | Withdrawn |
| 5380-1611-S | Depth 16 mm | Withdrawn |
| 5386-1610-S | Depth 16 mm | Withdrawn |
| 5346-1210-S | width(MLxAP), 14 x 12, mm | Withdrawn |
| 5366-1408-S | width(MLxAP), 16 x 14, mm | Withdrawn |
| 5360-1409-S | Depth 14 mm | Withdrawn |
| 5346-1205-S | Angle 6 ° | 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
1 recall names this product by its own identifier, 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 |
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.