Endoskeleton TA
Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Standard 12mm
14manufacturers in China registered for this device type
184catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Titan Spine, LLC, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K080615 |
| Record published | 2016-09-17 |
| 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 8 to 20 mm; depth 21 to 27 mm; width 32 to 40 mm; angle 7 to 12 °; length 10 to 21 in; width 10 in; height 2 to 4 in |
| Distribution end date | 2020-09-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 181-030-001 | In distribution | |
| 181-020-002 | In distribution | |
| 181-041-001 | In distribution | |
| 181-042-002 | In distribution | |
| 181-010-001 | In distribution | |
| 181-042-003 | In distribution | |
| 181-042-001 | In distribution | |
| 2106-1013 | Length 13 in | Withdrawn |
| 2107-0210-N | Lordotic Angle 7 Deg | Withdrawn |
| 2112-7314 | Height 14 mm | Withdrawn |
| 2312-9411 | Width 36 mm | Withdrawn |
| 2107-0316-S | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0212-N | Height 12 mm | Withdrawn |
| 2106-7316 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-9212 | Height 12 mm | Withdrawn |
| 2312-9417 | Width 36 mm | Withdrawn |
| 2112-7216 | Lordotic Angle 12 Deg | Withdrawn |
| 2107-0112-N | Height 12 mm | Withdrawn |
| 2112-9220 | width(MLxAP), 36 x 24, mm | Withdrawn |
| 2107-0310-N | Height 10 mm | Withdrawn |
| 2107-0213-N | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0214-S | Lordotic Angle 7 Deg | Withdrawn |
| 2112-9119 | Depth 21 mm | Withdrawn |
| 2106-9109 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0110-S | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0216-N | Lordotic Angle 7 Deg | Withdrawn |
| 2112-7316 | Lordotic Angle 12 Deg | Withdrawn |
| 2112-9318 | Depth 27 mm | Withdrawn |
| 2107-0311-N | Height 11 mm | Withdrawn |
| 2106-1014 | Length 21 in | Withdrawn |
| 2107-0315-N | Lordotic Angle 7 Deg | Withdrawn |
| 2106-9114 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-1014 | Length 21 in | Withdrawn |
| 2106-9213 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-7209 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-7216 | Height 16 mm | Withdrawn |
| 2312-9409 | Depth 21 mm | Withdrawn |
| 2106-7112 | Height 12 mm | Withdrawn |
| 2112-7214 | Lordotic Angle 12 Deg | Withdrawn |
| 2107-0216 | Height 16 mm | Withdrawn |
| 2107-0116-N | Height 16 mm | Withdrawn |
| 2106-9208 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0117-S | Height 17 mm | Withdrawn |
| 2106-7309 | Height 9 mm | Withdrawn |
| 2106-9312 | Lordotic Angle 7 Deg | Withdrawn |
| 2112-9218 | Height 18 mm | Withdrawn |
| 2106-7214 | Height 14 mm | Withdrawn |
| 2107-0215 | Height 15 mm | Withdrawn |
| 2112-7312 | Height 12 mm | Withdrawn |
| 2106-7210 | Height 10 mm | Withdrawn |
| 2107-0114 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0210-S | Lordotic Angle 7 Deg | Withdrawn |
| 2106-9317 | Height 17 mm | Withdrawn |
| 2106-9309 | Lordotic Angle 7 Deg | Withdrawn |
| 2112-7210 | Height 10 mm | Withdrawn |
| 2106-7310 | Height 10 mm | Withdrawn |
| 2107-0113-N | Height 13 mm | Withdrawn |
| 2107-0116 | Height 16 mm | Withdrawn |
| 2106-9314 | Height 14 mm | Withdrawn |
| 2107-0313 | Height 13 mm | Withdrawn |
| 2107-0311 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0115 | Height 15 mm | Withdrawn |
| 2107-0214 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0113-S | Height 13 mm | Withdrawn |
| 2107-0317-N | Height 17 mm | Withdrawn |
| 2106-7313 | Height 13 mm | Withdrawn |
| 2107-0113 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-7311 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0313-S | Height 13 mm | Withdrawn |
| 2106-9316 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0212-S | Height 12 mm | Withdrawn |
| 2107-0114-S | Lordotic Angle 7 Deg | Withdrawn |
| 2112-7113 | Lordotic Angle 12 Deg | Withdrawn |
| 2107-0116-S | Height 16 mm | Withdrawn |
| 2106-1006 | Length 10 in | Withdrawn |
| 2107-0212 | Height 12 mm | Withdrawn |
| 2107-0217-N | Height 17 mm | Withdrawn |
| 2112-7311 | Lordotic Angle 12 Deg | Withdrawn |
| 2112-7116 | Height 16 mm | Withdrawn |
| 2107-0213-S | Height 13 mm | Withdrawn |
| 2107-0310-S | Lordotic Angle 7 Deg | Withdrawn |
| 2106-7113 | Lordotic Angle 7 Deg | Withdrawn |
| 2312-9408 | Depth 21 mm | Withdrawn |
| 2106-9110 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0111-N | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0211-N | Lordotic Angle 7 Deg | Withdrawn |
| 2106-9215 | Height 15 mm | Withdrawn |
| 2107-0310 | Height 10 mm | Withdrawn |
| 2106-9113 | Height 13 mm | Withdrawn |
| 2112-9319 | Lordotic Angle 12 Deg | Withdrawn |
| 2106-9111 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0214-N | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0211-S | Height 11 mm | Withdrawn |
| 2106-7116 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0316-N | Height 16 mm | Withdrawn |
| 2106-1000 | Length 13 in | Withdrawn |
| 2107-0213 | Height 13 mm | Withdrawn |
| 2107-0312 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0110-N | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0117-N | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0217 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-9112 | Lordotic Angle 7 Deg | Withdrawn |
| 2312-9415 | Width 36 mm | Withdrawn |
| 2106-7312 | Height 12 mm | Withdrawn |
| 2106-9313 | Height 13 mm | Withdrawn |
| 2112-7310 | Lordotic Angle 12 Deg | Withdrawn |
| 2112-7115 | Height 15 mm | Withdrawn |
| 2106-1010 | Height 4 in | Withdrawn |
| 2106-9209 | Lordotic Angle 7 Deg | Withdrawn |
| 2112-7114 | Height 14 mm | Withdrawn |
| 2112-9320 | Angle 12 ° | Withdrawn |
| 2107-0312-S | Height 12 mm | Withdrawn |
| 2107-0210 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-7110 | Lordotic Angle 7 Deg | Withdrawn |
| 2112-7213 | Lordotic Angle 12 Deg | Withdrawn |
| 2106-1009 | Length 20 in | Withdrawn |
| 2107-0216-S | Height 16 mm | Withdrawn |
| 2106-7315 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-9210 | Height 10 mm | Withdrawn |
| 2106-7208 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0111-S | Height 11 mm | Withdrawn |
| 2106-9216 | Height 16 mm | Withdrawn |
| 2312-9413 | Depth 21 mm | Withdrawn |
| 2106-9117 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0112 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0117 | Height 17 mm | Withdrawn |
| 2107-0215-S | Height 15 mm | Withdrawn |
| 2106-7211 | Lordotic Angle 7 Deg | Withdrawn |
| 2112-9219 | width(MLxAP), 36 x 24, mm | Withdrawn |
| 2106-9315 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-9217 | Height 17 mm | Withdrawn |
| 2112-7111 | Height 11 mm | Withdrawn |
| 2112-7212 | Height 12 mm | Withdrawn |
| 2107-0315-S | Height 15 mm | Withdrawn |
| 2106-1002 | Length 10 in | Withdrawn |
| 2107-0114-N | Height 14 mm | Withdrawn |
| 2106-9115 | Height 15 mm | Withdrawn |
| 2106-9308 | Lordotic Angle 7 Deg | Withdrawn |
| 2112-7315 | Height 15 mm | Withdrawn |
| 2107-0311-S | Lordotic Angle 7 Deg | Withdrawn |
| 2112-7110 | Lordotic Angle 12 Deg | Withdrawn |
| 2107-0217-S | Height 17 mm | Withdrawn |
| 2106-7213 | Height 13 mm | Withdrawn |
| 2107-0115-S | Height 15 mm | Withdrawn |
| 2112-9118 | Width 32 mm | Withdrawn |
| 2106-1009 | Width 10 in | Withdrawn |
| 2106-7115 | Height 15 mm | Withdrawn |
| 2107-0316 | Lordotic Angle 7 Deg | Withdrawn |
| 2112-7313 | Height 13 mm | Withdrawn |
| 2107-0112-S | Height 12 mm | Withdrawn |
| 2107-0110 | Height 10 mm | Withdrawn |
| 2106-1003 | Length 12.5 in | Withdrawn |
| 2107-0314-S | Lordotic Angle 7 Deg | Withdrawn |
| 2106-7314 | Height 14 mm | Withdrawn |
| 2107-0313-N | Lordotic Angle 7 Deg | Withdrawn |
| 2106-7212 | Height 12 mm | Withdrawn |
| 2106-7114 | Height 14 mm | Withdrawn |
| 2107-0317-S | Height 17 mm | Withdrawn |
| 2106-7109 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-9310 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-1010 | Width 10 in | Withdrawn |
| 2112-7215 | Width 36 mm | Withdrawn |
| 2106-7308 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-9108 | Height 8 mm | Withdrawn |
| 2106-7111 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-9116 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-1001 | Withdrawn | |
| 2107-0312-N | Height 12 mm | Withdrawn |
| 2107-0314 | Lordotic Angle 7 Deg | Withdrawn |
| 2112-7112 | Lordotic Angle 12 Deg | Withdrawn |
| 2112-7211 | Height 11 mm | Withdrawn |
| 2106-9211 | Height 11 mm | Withdrawn |
| 2107-0215-N | Height 15 mm | Withdrawn |
| 2107-0315 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0111 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-7108 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-7215 | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0314-N | Height 14 mm | Withdrawn |
| 2107-0317 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-9311 | Lordotic Angle 7 Deg | Withdrawn |
| 2106-9214 | Lordotic Angle 7 Deg | Withdrawn |
| 2112-9120 | width(MLxAP), 32 x 21, mm | Withdrawn |
| 2107-0115-N | Lordotic Angle 7 Deg | Withdrawn |
| 2107-0211 | Height 11 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170399 | 2017-07-06 |
| K141953 | 2014-10-27 |
| K142589 | 2014-10-17 |
| K140055 | 2014-07-02 |
| K102067 | 2010-11-05 |
| K083714 | 2009-04-15 |
| K080615 | 2008-06-17 |
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 | 2021-03-17 | Class II | Packaging process control | The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device. | 11 devices | 2023-05-03 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.