Endoskeleton® TAS Sterile Barrier System
Interbody Fusion Device 12 Degree Standard 13mm
3manufacturers in China registered for this device type
68catalogue numbers in this listing
4510(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 | Titan Spine, LLC, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 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 | Height 10 to 20 mm; angle 7 to 12 °; depth 21 to 27 mm; width 32 to 40 mm |
| Distribution end date | 2021-03-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2312-0113-S | Angle 12 ° | Withdrawn |
| 2312-0212-S | Depth 24 mm | Withdrawn |
| 2307-0213-S | Angle 7 ° | Withdrawn |
| 2307-0116-S | width(MLxAP), 32 x 21, mm | Withdrawn |
| 2307-0317-S | Angle 7 ° | Withdrawn |
| 2312-0312-S | width(MLxAP), 40 x 27, mm | Withdrawn |
| 2304-1417-S | Height 14 mm | Withdrawn |
| 2307-0312-S | Angle 7 ° | Withdrawn |
| 2307-0113-S | Depth 21 mm | Withdrawn |
| 2312-0311-S | Angle 12 ° | Withdrawn |
| 2312-1112-S | width(MLxAP), 36 x 21, mm | Withdrawn |
| 2307-0115-S | Width 32 mm | Withdrawn |
| 2307-0214-S | Width 36 mm | Withdrawn |
| 2301-1821-S | Height 19 mm | Withdrawn |
| 2303-1417-S | Footprint, X-Large | Withdrawn |
| 2312-1116-S | Angle 12 ° | Withdrawn |
| 2312-0214-S | Angle 12 ° | Withdrawn |
| 2307-0114-S | Width 32 mm | Withdrawn |
| 2307-0216-S | Width 36 mm | Withdrawn |
| 2312-0313-S | width(MLxAP), 40 x 27, mm | Withdrawn |
| 2312-0310-S | Depth 27 mm | Withdrawn |
| 2312-0315-S | Width 40 mm | Withdrawn |
| 2312-0115-S | Width 32 mm | Withdrawn |
| 2307-0313-S | Depth 27 mm | Withdrawn |
| 2307-0217-S | Depth 24 mm | Withdrawn |
| 2307-0210-S | Angle 7 ° | Withdrawn |
| 2307-0316-S | Width 40 mm | Withdrawn |
| 2302-1821-S | Height 20 mm | Withdrawn |
| 2312-1115-S | Angle 12 ° | Withdrawn |
| 2312-0111-S | Angle 12 ° | Withdrawn |
| 2307-0310-S | Width 40 mm | Withdrawn |
| 2312-0213-S | Angle 12 ° | Withdrawn |
| 2312-0110-S | Depth 21 mm | Withdrawn |
| 2303-1013-S | Footprint, X-Large | Withdrawn |
| 2312-0316-S | Depth 27 mm | Withdrawn |
| 2312-0317-S | Depth 27 mm | Withdrawn |
| 2302-1013-S | For Use with Heights, 12mm to 13mm | Withdrawn |
| 2307-0215-S | Width 36 mm | Withdrawn |
| 2312-0117-S | width(MLxAP), 32 x 21, mm | Withdrawn |
| 2301-1013-S | For Use with Heights, 12mm to 13mm | Withdrawn |
| 2307-0314-S | width(MLxAP), 40 x 27, mm | Withdrawn |
| 2304-1821-S | Height 20 mm | Withdrawn |
| 2312-0116-S | width(MLxAP), 32 x 21, mm | Withdrawn |
| 2307-0311-S | width(MLxAP), 40 x 27, mm | Withdrawn |
| 2312-0216-S | Depth 24 mm | Withdrawn |
| 2307-0117-S | width(MLxAP), 32 x 21, mm | Withdrawn |
| 2303-1821-S | Height 18 mm | Withdrawn |
| 2312-0217-S | Width 36 mm | Withdrawn |
| 2312-0114-S | Width 32 mm | Withdrawn |
| 2302-1417-S | Height 17 mm | Withdrawn |
| 2312-1111-S | Depth 21 mm | Withdrawn |
| 2312-0210-S | width(MLxAP), 36 x 24, mm | Withdrawn |
| 2301-1417-S | Footprint, Standard | Withdrawn |
| 2312-1110-S | Depth 21 mm | Withdrawn |
| 2307-0212-S | Depth 24 mm | Withdrawn |
| 2312-1114-S | Depth 21 mm | Withdrawn |
| 2312-0211-S | Angle 12 ° | Withdrawn |
| 2307-0211-S | width(MLxAP), 36 x 24, mm | Withdrawn |
| 2312-0112-S | Angle 12 ° | Withdrawn |
| 2312-1113-S | Depth 21 mm | Withdrawn |
| 2307-0112-S | width(MLxAP), 32 x 21, mm | Withdrawn |
| 2312-1117-S | Width 36 mm | Withdrawn |
| 2307-0111-S | Depth 21 mm | Withdrawn |
| 2304-1013-S | For Use with Heights, 12mm to 13mm | Withdrawn |
| 2307-0110-S | width(MLxAP), 32 x 21, mm | Withdrawn |
| 2312-0314-S | Width 40 mm | Withdrawn |
| 2307-0315-S | Depth 27 mm | Withdrawn |
| 2312-0215-S | Width 36 mm | 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 |
|---|---|
| K191581 | 2020-01-08 |
| K192054 | 2019-08-29 |
| K163269 | 2017-04-13 |
| K111626 | 2011-09-09 |
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.