Endoskeleton® TAS
Interbody Fusion Device 12 Degree Standard 15mm
3manufacturers in China registered for this device type
56catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 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 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K111626 |
| 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 | Width 32 to 40 mm; angle 7 to 12 °; depth 21 to 27 mm; height 10 to 17 mm; length 20 to 30 mm; outer diameter 5.5 to 6.5 mm |
| Distribution end date | 2022-05-04 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2307-0113 | Width 32 mm | In distribution |
| 2312-0213 | Width 36 mm | In distribution |
| 2307-0115 | Depth 21 mm | In distribution |
| 2307-0213 | Width 36 mm | In distribution |
| 2312-0212 | width(MLxAP), 36 x 24, mm | In distribution |
| 2312-0115 | width(MLxAP), 32 x 21, mm | In distribution |
| 2312-0214 | width(MLxAP), 36 x 24, mm | In distribution |
| 2300-5520 | 5.5mm Diameter, 20mm Length | In distribution |
| 2312-0112 | Depth 21 mm | In distribution |
| 2307-0116 | Depth 21 mm | In distribution |
| 2312-0316 | Angle 12 ° | In distribution |
| 2307-0314 | Depth 27 mm | In distribution |
| 2312-0116 | Angle 12 ° | In distribution |
| 2307-0211 | width(MLxAP), 36 x 24, mm | In distribution |
| 2312-0317 | Angle 12 ° | In distribution |
| 2307-0317 | Angle 7 ° | In distribution |
| 2312-0210 | Width 36 mm | In distribution |
| 2307-0310 | Angle 7 ° | In distribution |
| 2312-0217 | Width 36 mm | In distribution |
| 2312-0310 | Angle 12 ° | In distribution |
| 2307-0316 | Angle 7 ° | In distribution |
| 2312-0113 | width(MLxAP), 32 x 21, mm | In distribution |
| 2307-0111 | Width 32 mm | In distribution |
| 2307-0313 | width(MLxAP), 40 x 27, mm | In distribution |
| 2300-5530 | 5.5mm Diameter, 30mm Length | In distribution |
| 2312-0311 | width(MLxAP), 40 x 27, mm | In distribution |
| 2307-0216 | Angle 7 ° | In distribution |
| 2300-6520 | Standard Bone Screw | In distribution |
| 2307-0117 | Depth 21 mm | In distribution |
| 2312-0110 | Width 32 mm | In distribution |
| 2300-6525 | 6.5mm Diameter, 25mm Length | In distribution |
| 2312-0111 | Width 32 mm | In distribution |
| 2312-0216 | width(MLxAP), 36 x 24, mm | In distribution |
| 2307-0210 | Depth 24 mm | In distribution |
| 2307-0112 | Angle 7 ° | In distribution |
| 2307-0110 | Depth 21 mm | In distribution |
| 2312-0211 | width(MLxAP), 36 x 24, mm | In distribution |
| 2300-6530 | Standard Bone Screw | In distribution |
| 2307-0312 | Width 40 mm | In distribution |
| 2300-5525 | 5.5mm Diameter, 25mm Length | In distribution |
| 2307-0114 | Width 32 mm | In distribution |
| 2312-0315 | Width 40 mm | In distribution |
| 2312-0314 | Depth 27 mm | In distribution |
| 2307-0315 | Depth 27 mm | In distribution |
| 2307-0217 | Depth 24 mm | In distribution |
| 2307-0212 | Width 36 mm | In distribution |
| 2307-0311 | Depth 27 mm | In distribution |
| 2312-0114 | Width 32 mm | In distribution |
| 2307-0215 | Angle 7 ° | In distribution |
| 2312-0117 | Depth 21 mm | In distribution |
| 2312-0312 | width(MLxAP), 40 x 27, mm | In distribution |
| 2312-0215 | Depth 24 mm | In distribution |
| 2312-0313 | width(MLxAP), 40 x 27, mm | In distribution |
| 2307-0214 | Angle 7 ° | In distribution |
| 2312-1115 | Angle 12 ° | Withdrawn |
| 2312-1117 | Angle 12 ° | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121982 | 2012-07-26 |
| K110063 | 2011-10-04 |
| K091813 | 2009-11-17 |
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 | 2021-09-02 | Class II | Packaging change control | Engraving on implants may not match what is listed on the pouch labels. | 10 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.