Endoskeleton TC
Endoskeleton TC is a titanium-alloy cervical interbody fusion cage. Its hollow centre is filled with autograft, and windows through the body allow the graft region to be viewed on imaging.…
Endoskeleton TC is a titanium-alloy cervical interbody fusion cage. Its hollow centre is filled with autograft, and windows through the body allow the graft region to be viewed on imaging.
The system provides different implant sizes for the cervical anatomy. The cage is placed through an anterior approach to support fusion between the treated vertebrae.
Listed Item
Interbody Fusion Device nanoLOCK Surface Technology Parallel Medium 10mm
Fusion Configuration
The described configuration is used at a single disc level from C3 to C7 in skeletally mature patients, with autograft and supplemental fixation.
7manufacturers in China registered for this device type
255catalogue 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) | K100889 |
| Record published | 2015-09-17 |
| Record revised | 2022-09-16 (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; width 14 to 18 mm; depth 12 to 16 mm; angle 6 °; length 7 to 21 in; height 1 to 6 in; width 6 to 10 in |
| Distribution end date | 2021-03-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5160-1409 | Height 9 mm | In distribution |
| 5160-1406 | Depth 14 mm | In distribution |
| 3051-0131 | In distribution | |
| 5160-1408 | Depth 14 mm | In distribution |
| 3051-0130 | In distribution | |
| 5146-1207-N | Lordotic Angle 6 Deg | Withdrawn |
| 5160-1410-S | Parallel | Withdrawn |
| 5240-1207 | Height 7 mm | Withdrawn |
| 5160-1411-S | Height 11 mm | Withdrawn |
| 5246-2206 | Lordotic Angle 6 Deg | Withdrawn |
| 5180-1605 | Depth 16 mm | Withdrawn |
| 5186-1607-S | Height 7 mm | Withdrawn |
| 5180-1607 | Height 7 mm | Withdrawn |
| 5900-1001 | Height 5 in | Withdrawn |
| 5186-1607 | Height 7 mm | Withdrawn |
| 5186-1610-S | Height 10 mm | Withdrawn |
| 5900-1005 | Height 1 in | Withdrawn |
| 5160-1410-N | Height 10 mm | Withdrawn |
| 5160-1405 | Height 5 mm | Withdrawn |
| 5140-1208-S | Parallel | Withdrawn |
| 5146-1211-N | Lordotic Angle 6 Deg | Withdrawn |
| 5260-1406 | Withdrawn | |
| 5160-1412-N | Parallel | Withdrawn |
| 5140-1212-N | Height 12 mm | Withdrawn |
| 5180-1612-N | Parallel | Withdrawn |
| 5266-2408 | Lordotic Angle 6 Deg | Withdrawn |
| 5140-1209 | Parallel | Withdrawn |
| 5260-1407 | Withdrawn | |
| 5166-1407-S | Lordotic Angle 6 Deg | Withdrawn |
| 5180-1608 | width(MLxAP), 18 x 16, mm | Withdrawn |
| 5140-1211-S | Parallel | Withdrawn |
| 5140-1209-S | Height 9 mm | Withdrawn |
| 5180-1612 | Height 12 mm | Withdrawn |
| 5140-1205 | Height 5 mm | Withdrawn |
| 5140-1208 | 14 x 12 (M/L x A/P) mm | Withdrawn |
| 5280-1606 | Parrallel | Withdrawn |
| 5140-1205-N | Height 5 mm | Withdrawn |
| 5160-1405-N | Parallel | Withdrawn |
| 5166-1406-S | Lordotic Angle 6 Deg | Withdrawn |
| 5286-2610 | Lordotic Angle 6 Deg | Withdrawn |
| 5186-1608 | Lordotic Angle 6 Deg | Withdrawn |
| 5180-1610-S | Parallel | Withdrawn |
| 5166-1410-N | Lordotic Angle 6 Deg | Withdrawn |
| 5160-1407 | Depth 14 mm | Withdrawn |
| 5186-1612-N | Lordotic Angle 6 Deg | Withdrawn |
| 5166-1408 | Lordotic Angle 6 Deg | Withdrawn |
| 5146-1206-N | Height 6 mm | Withdrawn |
| 5160-1408-S | Parallel | Withdrawn |
| 5186-1609-S | Lordotic Angle 6 Deg | Withdrawn |
| 5166-1411-N | Lordotic Angle 6 Deg | Withdrawn |
| 5160-1409-N | Height 9 mm | Withdrawn |
| 5186-1611-S | Height 11 mm | Withdrawn |
| 5180-1608-N | Height 8 mm | Withdrawn |
| 5900-1012 | Withdrawn | |
| 5146-1210-S | Lordotic Angle 6 Deg | Withdrawn |
| 5160-1410 | Height 10 mm | Withdrawn |
| 5266-2409 | Height 9 mm | Withdrawn |
| 5186-1605-S | Lordotic Angle 6 Deg | Withdrawn |
| 5180-1609 | Height 9 mm | Withdrawn |
| 5146-1209-N | Lordotic Angle 6 Deg | Withdrawn |
| 5140-1210 | Height 10 mm | Withdrawn |
| 5280-1605 | Withdrawn | |
| 5160-1408-N | Parallel | Withdrawn |
| 5140-1206-N | Parallel | Withdrawn |
| 5260-1405 | Withdrawn | |
| 5186-1610-N | Lordotic Angle 6 Deg | Withdrawn |
| 5166-1409-S | Lordotic Angle 6 Deg | Withdrawn |
| 5280-1611 | Withdrawn | |
| 5280-1609 | Parrallel | Withdrawn |
| 5166-1410-S | Lordotic Angle 6 Deg | Withdrawn |
| 5140-1211-N | Height 11 mm | Withdrawn |
| 5146-1207 | Lordotic Angle 6 Deg | Withdrawn |
| 5240-1211 | Withdrawn | |
| 5160-1407-N | Height 7 mm | Withdrawn |
| 5166-1411-S | Height 11 mm | Withdrawn |
| 5260-1406 | Height 6 mm | Withdrawn |
| 5160-1405 | Width 16 mm | Withdrawn |
| 5166-1410 | Lordotic Angle 6 Deg | Withdrawn |
| 5140-1205 | Parallel | Withdrawn |
| 5146-1205-S | Height 5 mm | Withdrawn |
| 5280-1705 | Length 8 in | Withdrawn |
| 5280-1610 | Withdrawn | |
| 5146-1212 | Lordotic Angle 6 Deg | Withdrawn |
| 5260-1412 | Parrallel | Withdrawn |
| 5140-1207 | Depth 12 mm | Withdrawn |
| 5240-1208 | Height 8 mm | Withdrawn |
| 5160-1407 | Parallel | Withdrawn |
| 5180-1606 | width(MLxAP), 18 x 16, mm | Withdrawn |
| 5166-1409-N | Height 9 mm | Withdrawn |
| 5140-1206 | Parallel | Withdrawn |
| 5140-1209-N | Height 9 mm | Withdrawn |
| 5180-1612 | Width 18 mm | Withdrawn |
| 5260-1410 | Parrallel | Withdrawn |
| 5900-1001 | Length 21 in | Withdrawn |
| 5146-1208-S | Lordotic Angle 6 Deg | Withdrawn |
| 5286-2611 | Lordotic Angle 6 Deg | Withdrawn |
| 5180-1608-S | width(MLxAP), 18 x 16, mm | Withdrawn |
| 5186-1609-N | Height 9 mm | Withdrawn |
| 5240-1209 | 14 x 12 (M/L x A/P) mm | Withdrawn |
| 5260-1408 | Withdrawn | |
| 5146-1206-S | Height 6 mm | Withdrawn |
| 5200-1003 | Length 9 in | Withdrawn |
| 5246-2212 | Height 12 mm | Withdrawn |
| 5160-1412 | Parallel | Withdrawn |
| 5260-1412 | Withdrawn | |
| 5166-1405-N | Lordotic Angle 6 Deg | Withdrawn |
| 5160-1407-S | Parallel | Withdrawn |
| 5266-2406 | Height 6 mm | Withdrawn |
| 5180-1606-N | Height 6 mm | Withdrawn |
| 5280-1609 | Withdrawn | |
| 5160-1412-S | Height 12 mm | Withdrawn |
| 5146-1211-S | Lordotic Angle 6 Deg | Withdrawn |
| 5140-1210 | Height 10 mm | Withdrawn |
| 5246-2210 | Height 10 mm | Withdrawn |
| 5180-1609 | Depth 16 mm | Withdrawn |
| 5140-1208 | Parallel | Withdrawn |
| 5140-1205-S | Height 5 mm | Withdrawn |
| 5180-1611 | width(MLxAP), 18 x 16, mm | Withdrawn |
| 5280-1606 | Withdrawn | |
| 5166-1406-N | Height 6 mm | Withdrawn |
| 5166-1407-N | Height 7 mm | Withdrawn |
| 5240-1210 | Withdrawn | |
| 5260-1405 | 16 x 14 (M/L x A/P) mm | Withdrawn |
| 5146-1210 | Lordotic Angle 6 Deg | Withdrawn |
| 5286-2605 | Height 5 mm | Withdrawn |
| 5266-2410 | Lordotic Angle 6 Deg | Withdrawn |
| 5186-1611-N | Height 11 mm | Withdrawn |
| 5140-1206 | width(MLxAP), 14 x 12, mm | Withdrawn |
| 5180-1607-S | Height 7 mm | Withdrawn |
| 5180-1607 | Height 7 mm | Withdrawn |
| 5260-1408 | 16 x 14 (M/L x A/P) mm | Withdrawn |
| 5900-1012 | Withdrawn | |
| 5160-1410 | Width 16 mm | Withdrawn |
| 5280-1607 | Withdrawn | |
| 5286-2612 | Lordotic Angle 6 Deg | Withdrawn |
| 5186-1607-N | Lordotic Angle 6 Deg | Withdrawn |
| 5246-2207 | Height 7 mm | Withdrawn |
| 5180-1607-N | Height 7 mm | Withdrawn |
| 5260-1411 | Withdrawn | |
| 5140-1208-N | Parallel | Withdrawn |
| 5166-1412 | Lordotic Angle 6 Deg | Withdrawn |
| 5166-1405-S | Height 5 mm | Withdrawn |
| 5186-1612 | Height 12 mm | Withdrawn |
| 5140-1211 | Height 11 mm | Withdrawn |
| 5146-1211 | Lordotic Angle 6 Deg | Withdrawn |
| 5260-1407 | Parrallel | Withdrawn |
| 5166-1407 | Height 7 mm | Withdrawn |
| 5166-1412-S | Lordotic Angle 6 Deg | Withdrawn |
| 5140-1209 | Width 14 mm | Withdrawn |
| 5266-2405 | Height 5 mm | Withdrawn |
| 5240-1210 | Parrallel | Withdrawn |
| 5200-1001 | Length 10 in | Withdrawn |
| 5160-1409 | Parallel | Withdrawn |
| 5260-1409 | Height 9 mm | Withdrawn |
| 5180-1610-N | Parallel | Withdrawn |
| 5140-1212 | Depth 12 mm | Withdrawn |
| 1005_041_001 | Withdrawn | |
| 5186-1611 | Lordotic Angle 6 Deg | Withdrawn |
| 5280-1607 | Height 7 mm | Withdrawn |
| 5166-1412-N | Lordotic Angle 6 Deg | Withdrawn |
| 5186-1608-N | width(MLxAP), 18 x 16, mm | Withdrawn |
| 5240-1208 | Withdrawn | |
| 5260-1410 | Withdrawn | |
| 5280-1608 | Parrallel | Withdrawn |
| 5280-1608 | Withdrawn | |
| 5180-1611-S | Height 11 mm | Withdrawn |
| 5180-1610 | Parallel | Withdrawn |
| 5286-2608 | Height 8 mm | Withdrawn |
| 5180-1605 | Height 5 mm | Withdrawn |
| 5240-1211 | Parrallel | Withdrawn |
| 5140-1206-S | Height 6 mm | Withdrawn |
| 5166-1409 | Height 9 mm | Withdrawn |
| 5140-1207-S | Parallel | Withdrawn |
| 5900-1005 | Length 7 in | Withdrawn |
| 5140-1211 | Depth 12 mm | Withdrawn |
| 5140-1210-S | Height 10 mm | Withdrawn |
| 5160-1408 | Height 8 mm | Withdrawn |
| 5286-2607 | Height 7 mm | Withdrawn |
| 5186-1606 | Lordotic Angle 6 Deg | Withdrawn |
| 5186-1612-S | Lordotic Angle 6 Deg | Withdrawn |
| 5180-1612-S | Height 12 mm | Withdrawn |
| 5160-1406 | Parallel | Withdrawn |
| 5266-2411 | Depth 14 mm | Withdrawn |
| 5146-1208 | Lordotic Angle 6 Deg | Withdrawn |
| 5186-1610 | Height 10 mm | Withdrawn |
| 5280-1605 | Parrallel | Withdrawn |
| 5160-1409-S | Height 9 mm | Withdrawn |
| 5180-1605-S | Height 5 mm | Withdrawn |
| 5186-1605-N | Height 5 mm | Withdrawn |
| 5140-1212-S | Parallel | Withdrawn |
| 5260-1411 | 16 x 14 (M/L x A/P) mm | Withdrawn |
| 5160-1411 | Parallel | Withdrawn |
| 5180-1605-N | Parallel | Withdrawn |
| 5140-1212 | Height 12 mm | Withdrawn |
| 5186-1605 | Lordotic Angle 6 Deg | Withdrawn |
| 5166-1405 | Lordotic Angle 6 Deg | Withdrawn |
| 5180-1609-N | Parallel | Withdrawn |
| 5160-1411 | Height 11 mm | Withdrawn |
| 5180-1611 | Height 11 mm | Withdrawn |
| 5266-2407 | Lordotic Angle 6 Deg | Withdrawn |
| 5286-2606 | Height 6 mm | Withdrawn |
| 5146-1209 | Height 9 mm | Withdrawn |
| 5160-1406-N | Parallel | Withdrawn |
| 5186-1606-S | Lordotic Angle 6 Deg | Withdrawn |
| 5900-1011 | Height 6 in | Withdrawn |
| 5140-1207-N | Height 7 mm | Withdrawn |
| 5160-1412 | width(MLxAP), 16 x 14, mm | Withdrawn |
| 5186-1609 | Height 9 mm | Withdrawn |
| 5146-1206 | Height 6 mm | Withdrawn |
| 5146-1212-S | Height 12 mm | Withdrawn |
| 5260-1409 | Withdrawn | |
| 5240-1205 | Withdrawn | |
| 5286-2609 | Lordotic Angle 6 Deg | Withdrawn |
| 5160-1405-S | Height 5 mm | Withdrawn |
| 5900-1011 | Width 10 in | Withdrawn |
| 5146-1208-N | Height 8 mm | Withdrawn |
| 5240-1206 | Parrallel | Withdrawn |
| 5240-1205 | Parrallel | Withdrawn |
| 5186-1606-N | Height 6 mm | Withdrawn |
| 5146-1209-S | Height 9 mm | Withdrawn |
| 5180-1606-S | Parallel | Withdrawn |
| 5140-1210-N | Height 10 mm | Withdrawn |
| 5280-1612 | Withdrawn | |
| 5166-1411 | Lordotic Angle 6 Deg | Withdrawn |
| 5166-1406 | width(MLxAP), 16 x 14, mm | Withdrawn |
| 5240-1209 | Withdrawn | |
| 5146-1207-S | Lordotic Angle 6 Deg | Withdrawn |
| 5246-2209 | Height 9 mm | Withdrawn |
| 5180-1606 | Height 6 mm | Withdrawn |
| 5146-1210-N | Height 10 mm | Withdrawn |
| 5180-1610 | 18 x 16 (M/L x A/P) mm | Withdrawn |
| 5280-1610 | Parrallel | Withdrawn |
| 5240-1207 | Withdrawn | |
| 5146-1205 | Height 5 mm | Withdrawn |
| 5240-1206 | Withdrawn | |
| 5246-2208 | Lordotic Angle 6 Deg | Withdrawn |
| 5146-1212-N | Lordotic Angle 6 Deg | Withdrawn |
| 5280-1612 | Height 12 mm | Withdrawn |
| 5280-1611 | 18 x 16 (M/L x A/P) mm | Withdrawn |
| 5166-1408-N | Lordotic Angle 6 Deg | Withdrawn |
| 5140-1207 | Height 7 mm | Withdrawn |
| 5246-2205 | Height 5 mm | Withdrawn |
| 1005_040_101 | Withdrawn | |
| 5180-1608 | Parallel | Withdrawn |
| 5186-1608-S | Lordotic Angle 6 Deg | Withdrawn |
| 5146-1205-N | Lordotic Angle 6 Deg | Withdrawn |
| 5160-1411-N | Parallel | Withdrawn |
| 5180-1609-S | Height 9 mm | Withdrawn |
| 5180-1611-N | Height 11 mm | Withdrawn |
| 5160-1406-S | Parallel | Withdrawn |
Showing 250 of 255 catalogue numbers.
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 |
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.