Endoskeleton® TL
Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 40 (M/L) 26 (A/P) 13 mm
14manufacturers in China registered for this device type
1,896catalogue 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) | K140055 |
| Record published | 2016-12-15 |
| 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 4 to 16 mm; width 3 to 26 mm; length 40 to 60 mm; angle 7 to 12 °; length 10 to 21 in; depth 18 to 22 mm; width 9 to 10 in; height 2 to 6 in |
| Distribution end date | 2021-02-24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7200-1196 | Height 6 mm | In distribution |
| 7200-1038 | Length 12 in | In distribution |
| 7200-1039 | Length 12 in | In distribution |
| 7200-1056 | Length 12 in | In distribution |
| 7207-1513 | Height 13 mm | In distribution |
| 7200-1055 | Width 3 mm | In distribution |
| 7200-1123 | In distribution | |
| 7900-1000-02 | Length 14 in | In distribution |
| 7200-1124 | In distribution | |
| 7200-1236 | Length 12.5 in | In distribution |
| 7200-1037 | Width 3 mm | In distribution |
| 7200-1040 | Width 5 mm | In distribution |
| 7200-1073 | Length 12 in | In distribution |
| 7200-1012 | In distribution | |
| 7900-1000-03 | Length 21 in | In distribution |
| 7200-1232 | Height 12 mm | In distribution |
| 7200-1230 | Length 12.5 in | In distribution |
| 7107-2509 | Angle 7 ° | Withdrawn |
| 7107-0214-N | Height 14 mm | Withdrawn |
| 7112-1113 | width(MLxAP), 40 x 22, mm | Withdrawn |
| 7300-0915 | Length 60 mm | Withdrawn |
| 7100-2509 | width(MLxAP), 60 x 26, mm | Withdrawn |
| 7100-2415 | width(MLxAP), 55 x 26, mm | Withdrawn |
| 7100-0508-S | Parallel | Withdrawn |
| 7100-2209-S | Width 26 mm | Withdrawn |
| 7107-2411-S | Width 26 mm | Withdrawn |
| 7100-0109 | width(MLxAP), 40 x 18, mm | Withdrawn |
| 7112-0213 | width(MLxAP), 45 x 18, mm | Withdrawn |
| 7112-2214 | width(MLxAP), 45 x 26, mm | Withdrawn |
| 7100-2113-N | Length 40 mm | Withdrawn |
| 7107-2516-N | Width 26 mm | Withdrawn |
| 7100-1414 | width(MLxAP), 55 x 22, mm | Withdrawn |
| 7200-0510 | Length 60 mm | Withdrawn |
| 7100-0313 | width(MLxAP), 50 x 18, mm | Withdrawn |
| 7100-1413-N | Height 13 mm | Withdrawn |
| 7112-2113-N | Length 40 mm | Withdrawn |
| 7200-1208 | Height 8 mm | Withdrawn |
| 7107-1513-N | Length 60 mm | Withdrawn |
| 7107-1512 | Width 22 mm | Withdrawn |
| 7100-1111-S | Height 11 mm | Withdrawn |
| 7100-0109-S | Length 40 mm | Withdrawn |
| 7107-0208-S | Length 45 mm | Withdrawn |
| 7112-1213 | Height 13 mm | Withdrawn |
| 7107-0316 | width(MLxAP), 50 x 18, mm | Withdrawn |
| 7107-2216 | Angle 7 ° | Withdrawn |
| 7200-1114 | Length 17 in | Withdrawn |
| 7100-2514 | Parallel | Withdrawn |
| 7107-2312-N | Lordotic Angle 7 Deg | Withdrawn |
| 7100-1408-S | Height 8 mm | Withdrawn |
| 7107-0211 | Width 18 mm | Withdrawn |
| 7112-1209 | Angle 12 ° | Withdrawn |
| 7107-2211 | Angle 7 ° | Withdrawn |
| 7100-1311 | Length 50 mm | Withdrawn |
| 7112-0212-N | Lordotic Angle 12 Deg | Withdrawn |
| 7112-2115 | width(MLxAP), 40 x 26, mm | Withdrawn |
| 7100-1416-S | Width 22 mm | Withdrawn |
| 7107-2414-N | Length 55 mm | Withdrawn |
| 7107-0512-N | width(MLxAP), 60 x 18, mm | Withdrawn |
| 7212-1513 | Angle 12 ° | Withdrawn |
| 7200-1137 | Width 18 mm | Withdrawn |
| 7200-1213 | Height 13 mm | Withdrawn |
| 7107-0415-S | Height 15 mm | Withdrawn |
| 7100-2311-S | Parallel | Withdrawn |
| 7112-2414 | width(MLxAP), 55 x 26, mm | Withdrawn |
| 7112-0408 | Lordotic Angle 12 Deg | Withdrawn |
| 7212-1508 | Length 60 mm | Withdrawn |
| 7100-1411-N | Height 11 mm | Withdrawn |
| 7112-2508-N | Height 8 mm | Withdrawn |
| 7112-2410-S | Length 55 mm | Withdrawn |
| 7300-1009 | Angle 12 ° | Withdrawn |
| 7107-1409-S | Angle 7 ° | Withdrawn |
| 7112-2314 | width(MLxAP), 50 x 26, mm | Withdrawn |
| 7100-1515-S | Parallel | Withdrawn |
| 7300-1215 | Angle 7 ° | Withdrawn |
| 7100-2408 | Width 26 mm | Withdrawn |
| 7112-1113 | Lordotic Angle 12 Deg | Withdrawn |
| 7100-1212-N | Length 45 mm | Withdrawn |
| 7107-0408-S | width(MLxAP), 55 x 18, mm | Withdrawn |
| 7107-0414-S | Length 55 mm | Withdrawn |
| 7112-0110-N | Lordotic Angle 12 Deg | Withdrawn |
| 7112-2310 | width(MLxAP), 50 x 26, mm | Withdrawn |
| 7100-0413 | Length 55 mm | Withdrawn |
| 7112-1316 | Width 22 mm | Withdrawn |
| 845-030-101 | Withdrawn | |
| 7300-1112 | Lordotic Angle 7 Deg | Withdrawn |
| 7100-2416-S | Length 55 mm | Withdrawn |
| 7112-1309 | width(MLxAP), 50 x 22, mm | Withdrawn |
| 7100-1113-S | Length 40 mm | Withdrawn |
| 7112-2309-S | Lordotic Angle 12 Deg | Withdrawn |
| 7100-0308 | Length 50 mm | Withdrawn |
| 7112-1216-N | Lordotic Angle 12 Deg | Withdrawn |
| 7112-2415-N | Width 26 mm | Withdrawn |
| 7112-0514-S | Height 14 mm | Withdrawn |
| 7107-1108 | Lordotic Angle 7 Deg | Withdrawn |
| 7200-1103 | Length 17 in | Withdrawn |
| 7100-2115-N | Width 26 mm | Withdrawn |
| 7200-1026 | Length 16 in | Withdrawn |
| 7107-1216-N | Angle 7 ° | Withdrawn |
| 7107-0212 | Width 18 mm | Withdrawn |
| 7107-2513 | Angle 7 ° | Withdrawn |
| 7200-2515 | Length 60 mm | Withdrawn |
| 7200-1170 | Width 18 mm | Withdrawn |
| 7112-2409 | width(MLxAP), 55 x 26, mm | Withdrawn |
| 7100-2209-N | Length 45 mm | Withdrawn |
| 7107-1216 | Length 45 mm | Withdrawn |
| 7107-2514-N | Lordotic Angle 7 Deg | Withdrawn |
| 7112-1410-N | Length 55 mm | Withdrawn |
| 7107-1316-N | Length 50 mm | Withdrawn |
| 1000-0074 | Withdrawn | |
| 7112-1514-S | Width 22 mm | Withdrawn |
| 7300-1015 | Lordotic Angle 12 Deg | Withdrawn |
| 7200-1513 | Length 60 mm | Withdrawn |
| 7200-1104 | Length 17 in | Withdrawn |
| 7100-1116-N | Width 22 mm | Withdrawn |
| 7100-1210 | Width 22 mm | Withdrawn |
| 7112-0311 | Angle 12 ° | Withdrawn |
| 7112-1114-N | Length 40 mm | Withdrawn |
| 7112-2116-N | Width 26 mm | Withdrawn |
| 7107-2416-S | Lordotic Angle 7 Deg | Withdrawn |
| 7112-2112-N | Height 12 mm | Withdrawn |
| 7100-2516 | Length 60 mm | Withdrawn |
| 7107-2216-S | Width 26 mm | Withdrawn |
| 7112-1108 | Angle 12 ° | Withdrawn |
| 7112-1414 | width(MLxAP), 55 x 22, mm | Withdrawn |
| 7112-2309 | Height 9 mm | Withdrawn |
| 7212-2513 | Height 13 mm | Withdrawn |
| 7100-2313-N | Length 50 mm | Withdrawn |
| 7100-0315 | Length 50 mm | Withdrawn |
| 7107-1410-S | Length 55 mm | Withdrawn |
| 7112-1108 | Height 8 mm | Withdrawn |
| 7112-2216-S | Height 16 mm | Withdrawn |
| 7100-0312-N | Height 12 mm | Withdrawn |
| 7107-2309 | Width 26 mm | Withdrawn |
| 7100-0513-N | Parallel | Withdrawn |
| 7200-1249 | Height 9 mm | Withdrawn |
| 7300-0912 | Length 60 mm | Withdrawn |
| 7100-0310 | Length 50 mm | Withdrawn |
| 7107-0308-S | Width 18 mm | Withdrawn |
| 7112-0415 | width(MLxAP), 55 x 18, mm | Withdrawn |
| 7107-0111-N | Width 18 mm | Withdrawn |
| 7107-2316 | Length 50 mm | Withdrawn |
| 7107-2514-S | Lordotic Angle 7 Deg | Withdrawn |
| 7112-1208 | width(MLxAP), 45 x 22, mm | Withdrawn |
| 7212-0514 | Lordotic Angle 12 Deg | Withdrawn |
| 7107-1210 | Width 22 mm | Withdrawn |
| 7900-1004 | Width 10 in | Withdrawn |
| 7112-2511 | Angle 12 ° | Withdrawn |
| 7107-2511 | Height 11 mm | Withdrawn |
| 7200-1033 | Length 12 in | Withdrawn |
| 7207-1509 | Width 22 mm | Withdrawn |
| 7112-2212 | Angle 12 ° | Withdrawn |
| 7112-2413 | Lordotic Angle 12 Deg | Withdrawn |
| 7112-2315 | Lordotic Angle 12 Deg | Withdrawn |
| 7200-1118 | Width 18 mm | Withdrawn |
| 7100-0508 | Height 8 mm | Withdrawn |
| 7112-0110 | Angle 12 ° | Withdrawn |
| 7107-2516 | width(MLxAP), 60 x 26, mm | Withdrawn |
| 7200-1022 | Length 16 in | Withdrawn |
| 7100-1210-S | Width 22 mm | Withdrawn |
| 7200-1013 | Length 16 in | Withdrawn |
| 7107-0214 | Length 45 mm | Withdrawn |
| 7107-1112-S | Height 12 mm | Withdrawn |
| 7100-2413-S | Parallel | Withdrawn |
| 7107-0108 | Length 40 mm | Withdrawn |
| 7100-1410 | Height 10 mm | Withdrawn |
| 7100-1214 | Parallel | Withdrawn |
| 7100-0113-N | Height 13 mm | Withdrawn |
| 7200-1101 | Length 17 in | Withdrawn |
| 7107-0215 | Lordotic Angle 7 Deg | Withdrawn |
| 7201-0516 | Width 18 mm | Withdrawn |
| 7112-1310-S | Angle 12 ° | Withdrawn |
| 7100-2213-S | Parallel | Withdrawn |
| 7200-7111 | Height 11 mm | Withdrawn |
| 7112-1511 | Height 11 mm | Withdrawn |
| 7107-2311-S | Height 11 mm | Withdrawn |
| 7100-2315 | width(MLxAP), 50 x 26, mm | Withdrawn |
| 7200-2509 | Length 60 mm | Withdrawn |
| 7100-2515-N | Parallel | Withdrawn |
| 7200-1207 | Length 12.5 in | Withdrawn |
| 7100-0511-N | Height 11 mm | Withdrawn |
| 7107-0411-S | Width 18 mm | Withdrawn |
| 7107-2112-S | Height 12 mm | Withdrawn |
| 7112-1112 | Lordotic Angle 12 Deg | Withdrawn |
| 7107-2408-N | width(MLxAP), 55 x 26, mm | Withdrawn |
| 7200-1062 | Length 11 in | Withdrawn |
| 7107-0315-S | Length 50 mm | Withdrawn |
| 7100-0309 | Length 50 mm | Withdrawn |
| 7112-0215-S | Angle 12 ° | Withdrawn |
| 7107-0116 | Angle 7 ° | Withdrawn |
| 7107-0310 | Length 50 mm | Withdrawn |
| 7200-1078 | Width 10 mm | Withdrawn |
| 7112-2516-S | Width 26 mm | Withdrawn |
| 7201-2513 | width(MLxAP), 60 x 26, mm | Withdrawn |
| 7112-2208-S | Lordotic Angle 12 Deg | Withdrawn |
| 7300-1411 | width(MLxAP), 60 x 22, mm | Withdrawn |
| 7112-1512-N | Height 12 mm | Withdrawn |
| 7112-0508 | Length 60 mm | Withdrawn |
| 7100-1209 | Width 22 mm | Withdrawn |
| 7201-1513 | Height 13 mm | Withdrawn |
| 7200-1113 | Length 17 in | Withdrawn |
| 7300-1308 | Length 60 mm | Withdrawn |
| 7200-1064 | Length 16 in | Withdrawn |
| 7107-2511-S | width(MLxAP), 60 x 26, mm | Withdrawn |
| 7300-1210 | Height 10 mm | Withdrawn |
| 7200-1175 | Length 12.5 in | Withdrawn |
| 7107-1311 | Lordotic Angle 7 Deg | Withdrawn |
| 7107-1213 | Angle 7 ° | Withdrawn |
| 7112-1309-N | Width 22 mm | Withdrawn |
| 7100-0408-N | Height 8 mm | Withdrawn |
| 7107-2512-N | Height 12 mm | Withdrawn |
| 7100-2412 | Length 55 mm | Withdrawn |
| 7200-1134 | Height 4 mm | Withdrawn |
| 7107-0213-N | Height 13 mm | Withdrawn |
| 7100-2115-S | Length 40 mm | Withdrawn |
| 7112-0411-S | Width 18 mm | Withdrawn |
| 7200-1158 | Width 26 mm | Withdrawn |
| 7200-1097 | Width 26 mm | Withdrawn |
| 7100-0214-N | Height 14 mm | Withdrawn |
| 7112-2309 | Angle 12 ° | Withdrawn |
| 7112-1310 | Lordotic Angle 12 Deg | Withdrawn |
| 7100-0414 | Width 18 mm | Withdrawn |
| 7100-2208-N | Width 26 mm | Withdrawn |
| 7100-2213 | width(MLxAP), 45 x 26, mm | Withdrawn |
| 7100-0408 | Height 8 mm | Withdrawn |
| 7112-2215 | width(MLxAP), 45 x 26, mm | Withdrawn |
| 7100-0415-N | Parallel | Withdrawn |
| 7100-0111 | Length 40 mm | Withdrawn |
| 7100-0514-S | Height 14 mm | Withdrawn |
| 7107-0515 | Angle 7 ° | Withdrawn |
| 7200-1129 | Width 18 mm | Withdrawn |
| 7100-0110-N | Parallel | Withdrawn |
| 7300-1111 | Lordotic Angle 7 Deg | Withdrawn |
| 7100-0209 | width(MLxAP), 45 x 18, mm | Withdrawn |
| 7112-0112-N | Lordotic Angle 12 Deg | Withdrawn |
| 7107-0513 | Width 18 mm | Withdrawn |
| 7112-0515-N | Lordotic Angle 12 Deg | Withdrawn |
| 7100-0113-S | Width 18 mm | Withdrawn |
| 7100-1513-S | Length 60 mm | Withdrawn |
| 7100-0110-S | Length 40 mm | Withdrawn |
| 7100-1308-N | Parallel | Withdrawn |
| 7100-0209 | Length 45 mm | Withdrawn |
| 7107-0113-N | Width 18 mm | Withdrawn |
| 7100-1515 | Width 22 mm | Withdrawn |
| 7112-2312 | Lordotic Angle 12 Deg | Withdrawn |
| 7112-1208 | Lordotic Angle 12 Deg | Withdrawn |
| 7100-0109 | Width 18 mm | Withdrawn |
| 7100-1415 | width(MLxAP), 55 x 22, mm | Withdrawn |
| 7107-0315 | width(MLxAP), 50 x 18, mm | Withdrawn |
| 7212-0508 | Height 8 mm | Withdrawn |
| 7100-0510-N | Parallel | Withdrawn |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| LnK Lumbar Interbody Fusion Cage System/PathLoc-LC Lateral Cage System | L&K Biomed Co., Ltd. | 1,410 |
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.