Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology
Interbody Fusion Device 20 Degree 50 (M/L) 22 (A/P) 14 mm
3manufacturers in China registered for this device type
462catalogue 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 | 2020-08-15 |
| Record revised | 2025-07-14 (version 4) |
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 | Length 40 to 60 mm; angle 16 to 30 °; width 18 to 26 mm; height 9 to 20 mm |
| Distribution end date | 2021-02-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7120-1314-N | Length 50 mm | In distribution |
| 7130-1516-N | Height 16 mm | In distribution |
| 7116-0416-N | Height 16 mm | In distribution |
| 7120-1218-N | Height 18 mm | In distribution |
| 7116-0212-N | width(MLxAP), 45 x 18, mm | In distribution |
| 7116-0518-N | width(MLxAP), 60 x 18, mm | In distribution |
| 7120-1318-N | Length 50 mm | In distribution |
| 7120-1418-N | Width 22 mm | In distribution |
| 7116-0318-N | Length 50 mm | In distribution |
| 7120-1518-N | width(MLxAP), 60 x 22, mm | In distribution |
| 7116-0216-N | Height 16 mm | In distribution |
| 7116-0516-N | Lordotic Angle – 16 Deg | In distribution |
| 7116-0414-N | width(MLxAP), 55 x 18, mm | In distribution |
| 7116-0314-N | Length 50 mm | In distribution |
| 7120-1412-N | width(MLxAP), 55 x 22, mm | In distribution |
| 7116-0214-N | width(MLxAP), 45 x 18, mm | In distribution |
| 7120-1214-N | Height 14 mm | In distribution |
| 7130-1518-N | Lordotic Angle – 30 Deg | In distribution |
| 7120-1512-N | Width 22 mm | In distribution |
| 7116-0410-N | Lordotic Angle – 16 Deg | In distribution |
| 7130-1320-N | Length 50 mm | In distribution |
| 7130-1420-N | width(MLxAP), 55 x 22, mm | In distribution |
| 7120-1516-N | width(MLxAP), 60 x 22, mm | In distribution |
| 7130-1216-N | width(MLxAP), 45 x 22, mm | In distribution |
| 7120-1220-N | Length 45 mm | In distribution |
| 7130-1316-N | width(MLxAP), 50 x 22, mm | In distribution |
| 7130-1220-N | Width 22 mm | In distribution |
| 7120-1514-N | Width 22 mm | In distribution |
| 7120-1520-N | Angle 20 ° | In distribution |
| 7120-1320-N | Length 50 mm | In distribution |
| 7120-1312-N | Lordotic Angle – 20 Deg | In distribution |
| 7120-1316-N | width(MLxAP), 50 x 22, mm | In distribution |
| 7116-0310-N | Lordotic Angle – 16 Deg | In distribution |
| 7120-1420-N | Lordotic Angle – 20 Deg | In distribution |
| 7130-1318-N | Lordotic Angle – 30 Deg | In distribution |
| 7120-1416-N | Length 55 mm | In distribution |
| 7120-1414-N | Length 55 mm | In distribution |
| 7120-1212-N | Length 45 mm | In distribution |
| 7120-1216-N | Width 22 mm | In distribution |
| 7130-1520-N | Width 22 mm | In distribution |
| 7130-1416-N | Length 55 mm | In distribution |
| 7116-0316-N | width(MLxAP), 50 x 18, mm | In distribution |
| 7116-0412-N | Width 18 mm | In distribution |
| 7116-0418-N | width(MLxAP), 55 x 18, mm | In distribution |
| 7124-0414-N | Angle 24 ° | Withdrawn |
| 7116-0211-N | Lordotic Angle – 16 Deg | Withdrawn |
| 7116-0417-N | Length 55 mm | Withdrawn |
| 7124-1416-N | Lordotic Angle – 24 Deg | Withdrawn |
| 7116-2113-N | Height 13 mm | Withdrawn |
| 7120-0516-N | Lordotic Angle – 20 Deg | Withdrawn |
| 7116-1217-N | Lordotic Angle – 16 Deg | Withdrawn |
| 7120-0118-N | Lordotic Angle – 20 Deg | Withdrawn |
| 7120-2115-N | Height 15 mm | Withdrawn |
| 7130-0517-N | Angle 30 ° | Withdrawn |
| 7116-1515-N | Width 22 mm | Withdrawn |
| 7130-2518-N | Lordotic Angle – 30 Deg | Withdrawn |
| 7124-0120-N | Lordotic Angle – 24 Deg | Withdrawn |
| 7130-1119-N | Width 22 mm | Withdrawn |
| 7116-0117-N | Height 17 mm | Withdrawn |
| 7130-1319-N | width(MLxAP), 50 x 22, mm | Withdrawn |
| 7130-1219-N | width(MLxAP), 45 x 22, mm | Withdrawn |
| 7116-1317-N | Width 22 mm | Withdrawn |
| 7120-2219-N | Length 45 mm | Withdrawn |
| 7124-1414-N | Length 55 mm | Withdrawn |
| 7120-0215-N | Length 45 mm | Withdrawn |
| 7130-0218-N | Length 45 mm | Withdrawn |
| 7120-2414-N | width(MLxAP), 55 x 26, mm | Withdrawn |
| 7120-2314-N | width(MLxAP), 50 x 26, mm | Withdrawn |
| 7124-0419-N | Height 19 mm | Withdrawn |
| 7116-1311-N | Height 11 mm | Withdrawn |
| 7116-1314-N | Width 22 mm | Withdrawn |
| 7124-0214-N | Length 45 mm | Withdrawn |
| 7116-1313-N | Angle 16 ° | Withdrawn |
| 7124-0314-N | Width 18 mm | Withdrawn |
| 7124-2118-N | Angle 24 ° | Withdrawn |
| 7116-1216-N | Length 45 mm | Withdrawn |
| 7120-2114-N | width(MLxAP), 40 x 26, mm | Withdrawn |
| 7120-0120-N | width(MLxAP), 40 x 18, mm | Withdrawn |
| 7124-1219-N | Length 45 mm | Withdrawn |
| 7124-0113-N | Height 13 mm | Withdrawn |
| 7120-2315-N | Lordotic Angle – 20 Deg | Withdrawn |
| 7116-0317-N | Length 50 mm | Withdrawn |
| 7116-1413-N | width(MLxAP), 55 x 22, mm | Withdrawn |
| 7124-1114-N | width(MLxAP), 40 x 22, mm | Withdrawn |
| 7120-2319-N | Length 50 mm | Withdrawn |
| 7120-0416-N | Lordotic Angle – 20 Deg | Withdrawn |
| 7116-1111-N | Height 11 mm | Withdrawn |
| 7120-2518-N | Lordotic Angle – 20 Deg | Withdrawn |
| 7124-0415-N | Width 18 mm | Withdrawn |
| 7130-0420-N | Angle 30 ° | Withdrawn |
| 7120-1417-N | Length 55 mm | Withdrawn |
| 7130-0415-N | Height 15 mm | Withdrawn |
| 7116-2216-N | Width 26 mm | Withdrawn |
| 7116-0409-N | Lordotic Angle – 16 Deg | Withdrawn |
| 7116-1113-N | width(MLxAP), 40 x 22, mm | Withdrawn |
| 7116-1514-N | Angle 16 ° | Withdrawn |
| 7116-1316-N | Height 16 mm | Withdrawn |
| 7124-1214-N | Length 45 mm | Withdrawn |
| 7116-0109-N | width(MLxAP), 40 x 18, mm | Withdrawn |
| 7130-1116-N | Angle 30 ° | Withdrawn |
| 7120-1219-N | Lordotic Angle – 20 Deg | Withdrawn |
| 7116-1119-N | Width 22 mm | Withdrawn |
| 7124-1115-N | Length 40 mm | Withdrawn |
| 7130-0315-N | Lordotic Angle – 30 Deg | Withdrawn |
| 7116-2418-N | Width 26 mm | Withdrawn |
| 7116-1420-N | Length 55 mm | Withdrawn |
| 7116-0411-N | width(MLxAP), 55 x 18, mm | Withdrawn |
| 7120-2419-N | Width 26 mm | Withdrawn |
| 7116-0420-N | Lordotic Angle – 16 Deg | Withdrawn |
| 7130-0118-N | Length 40 mm | Withdrawn |
| 7116-0213-N | Height 13 mm | Withdrawn |
| 7124-1420-N | width(MLxAP), 55 x 22, mm | Withdrawn |
| 7124-0412-N | Width 18 mm | Withdrawn |
| 7120-0212-N | Width 18 mm | Withdrawn |
| 7120-0313-N | Length 50 mm | Withdrawn |
| 7124-1418-N | Length 55 mm | Withdrawn |
| 7124-1517-N | Lordotic Angle – 24 Deg | Withdrawn |
| 7120-0315-N | Lordotic Angle – 20 Deg | Withdrawn |
| 7116-1218-N | Length 45 mm | Withdrawn |
| 7120-2220-N | width(MLxAP), 45 x 26, mm | Withdrawn |
| 7116-1215-N | Width 22 mm | Withdrawn |
| 7120-0116-N | width(MLxAP), 40 x 18, mm | Withdrawn |
| 7124-2318-N | Width 26 mm | Withdrawn |
| 7116-1320-N | Height 20 mm | Withdrawn |
| 7124-1417-N | Angle 24 ° | Withdrawn |
| 7116-2416-N | Width 26 mm | Withdrawn |
| 7130-2320-N | Length 50 mm | Withdrawn |
| 7130-0414-N | Height 14 mm | Withdrawn |
| 7116-2120-N | Lordotic Angle – 16 Deg | Withdrawn |
| 7124-2117-N | Angle 24 ° | Withdrawn |
| 7130-0417-N | Angle 30 ° | Withdrawn |
| 7116-2317-N | Length 50 mm | Withdrawn |
| 7120-0517-N | Lordotic Angle – 20 Deg | Withdrawn |
| 7120-0117-N | Angle 20 ° | Withdrawn |
| 7116-2515-N | width(MLxAP), 60 x 26, mm | Withdrawn |
| 7124-0112-N | width(MLxAP), 40 x 18, mm | Withdrawn |
| 7130-1120-N | Height 20 mm | Withdrawn |
| 7120-0112-N | Height 12 mm | Withdrawn |
| 7124-0318-N | Height 18 mm | Withdrawn |
| 7120-0320-N | width(MLxAP), 50 x 18, mm | Withdrawn |
| 7120-2416-N | Lordotic Angle – 20 Deg | Withdrawn |
| 7116-0511-N | Height 11 mm | Withdrawn |
| 7116-0517-N | Height 17 mm | Withdrawn |
| 7124-0512-N | Height 12 mm | Withdrawn |
| 7124-1216-N | Length 45 mm | Withdrawn |
| 7120-0114-N | Width 18 mm | Withdrawn |
| 7116-1513-N | width(MLxAP), 60 x 22, mm | Withdrawn |
| 7130-0216-N | Lordotic Angle – 30 Deg | Withdrawn |
| 7116-2119-N | Length 40 mm | Withdrawn |
| 7130-0416-N | Lordotic Angle – 30 Deg | Withdrawn |
| 7116-2312-N | Lordotic Angle – 16 Deg | Withdrawn |
| 7120-1215-N | width(MLxAP), 45 x 22, mm | Withdrawn |
| 7116-1210-N | Angle 16 ° | Withdrawn |
| 7124-1217-N | Lordotic Angle – 24 Deg | Withdrawn |
| 7124-1320-N | Angle 24 ° | Withdrawn |
| 7120-1315-N | Angle 20 ° | Withdrawn |
| 7130-2220-N | Angle 30 ° | Withdrawn |
| 7124-1415-N | Height 15 mm | Withdrawn |
| 7120-2316-N | Lordotic Angle – 20 Deg | Withdrawn |
| 7116-2319-N | Height 19 mm | Withdrawn |
| 7120-0317-N | Lordotic Angle – 20 Deg | Withdrawn |
| 7124-1218-N | Length 45 mm | Withdrawn |
| 7130-0114-N | width(MLxAP), 40 x 18, mm | Withdrawn |
| 7120-0520-N | Length 60 mm | Withdrawn |
| 7124-0115-N | Angle 24 ° | Withdrawn |
| 7124-0317-N | width(MLxAP), 50 x 18, mm | Withdrawn |
| 7130-0219-N | Width 18 mm | Withdrawn |
| 7120-0219-N | Length 45 mm | Withdrawn |
| 7116-0112-N | Height 12 mm | Withdrawn |
| 7116-2218-N | Lordotic Angle – 16 Deg | Withdrawn |
| 7116-0313-N | Length 50 mm | Withdrawn |
| 7130-0115-N | Lordotic Angle – 30 Deg | Withdrawn |
| 7120-2418-N | width(MLxAP), 55 x 26, mm | Withdrawn |
| 7124-1520-N | Width 22 mm | Withdrawn |
| 7124-1314-N | Width 22 mm | Withdrawn |
| 7130-2118-N | Length 40 mm | Withdrawn |
| 7116-0217-N | Width 18 mm | Withdrawn |
| 7120-2417-N | Height 17 mm | Withdrawn |
| 7124-1519-N | Lordotic Angle – 24 Deg | Withdrawn |
| 7124-2519-N | Lordotic Angle – 24 Deg | Withdrawn |
| 7130-0418-N | width(MLxAP), 55 x 18, mm | Withdrawn |
| 7130-2419-N | Length 55 mm | Withdrawn |
| 7124-2316-N | Width 26 mm | Withdrawn |
| 7116-1416-N | Lordotic Angle – 16 Deg | Withdrawn |
| 7124-0518-N | Angle 24 ° | Withdrawn |
| 7124-0119-N | Length 40 mm | Withdrawn |
| 7116-2315-N | Height 15 mm | Withdrawn |
| 7116-2419-N | Height 19 mm | Withdrawn |
| 7124-0320-N | Length 50 mm | Withdrawn |
| 7120-1118-N | Width 22 mm | Withdrawn |
| 7124-1215-N | Lordotic Angle – 24 Deg | Withdrawn |
| 7130-0214-N | Length 45 mm | Withdrawn |
| 7120-1112-N | width(MLxAP), 40 x 22, mm | Withdrawn |
| 7116-2115-N | Lordotic Angle – 16 Deg | Withdrawn |
| 7116-1516-N | Length 60 mm | Withdrawn |
| 7130-1417-N | width(MLxAP), 55 x 22, mm | Withdrawn |
| 7130-0215-N | Height 15 mm | Withdrawn |
| 7116-1410-N | Height 10 mm | Withdrawn |
| 7120-0211-N | Length 45 mm | Withdrawn |
| 7116-0519-N | Height 19 mm | Withdrawn |
| 7116-2114-N | width(MLxAP), 40 x 26, mm | Withdrawn |
| 7116-0419-N | width(MLxAP), 55 x 18, mm | Withdrawn |
| 7124-1315-N | Angle 24 ° | Withdrawn |
| 7120-0319-N | Angle 20 ° | Withdrawn |
| 7120-2116-N | Angle 20 ° | Withdrawn |
| 7116-1212-N | Height 12 mm | Withdrawn |
| 7124-1518-N | width(MLxAP), 60 x 22, mm | Withdrawn |
| 7130-0520-N | Lordotic Angle – 30 Deg | Withdrawn |
| 7130-0516-N | width(MLxAP), 60 x 18, mm | Withdrawn |
| 7130-0514-N | Lordotic Angle – 30 Deg | Withdrawn |
| 7116-0515-N | Length 60 mm | Withdrawn |
| 7116-0114-N | Height 14 mm | Withdrawn |
| 7130-1117-N | width(MLxAP), 40 x 22, mm | Withdrawn |
| 7116-0115-N | width(MLxAP), 40 x 18, mm | Withdrawn |
| 7130-0320-N | Width 18 mm | Withdrawn |
| 7124-1120-N | Height 20 mm | Withdrawn |
| 7130-0120-N | Length 40 mm | Withdrawn |
| 7120-1413-N | Lordotic Angle – 20 Deg | Withdrawn |
| 7124-0513-N | Width 18 mm | Withdrawn |
| 7124-0219-N | Length 45 mm | Withdrawn |
| 7124-0520-N | width(MLxAP), 60 x 18, mm | Withdrawn |
| 7116-0111-N | Width 18 mm | Withdrawn |
| 7130-0317-N | Height 17 mm | Withdrawn |
| 7120-0414-N | Width 18 mm | Withdrawn |
| 7116-0110-N | width(MLxAP), 40 x 18, mm | Withdrawn |
| 7120-0213-N | Width 18 mm | Withdrawn |
| 7116-1112-N | Lordotic Angle – 16 Deg | Withdrawn |
| 7116-1414-N | Width 22 mm | Withdrawn |
| 7116-1117-N | Lordotic Angle – 16 Deg | Withdrawn |
| 7120-0113-N | Height 13 mm | Withdrawn |
| 7116-1116-N | Length 40 mm | Withdrawn |
| 7120-0216-N | Angle 20 ° | Withdrawn |
| 7116-1214-N | Angle 16 ° | Withdrawn |
| 7120-1115-N | width(MLxAP), 40 x 22, mm | Withdrawn |
| 7124-0215-N | Height 15 mm | Withdrawn |
| 7120-1116-N | Width 22 mm | Withdrawn |
| 7120-0111-N | Height 11 mm | Withdrawn |
| 7116-0116-N | Height 16 mm | Withdrawn |
| 7130-0316-N | Height 16 mm | Withdrawn |
| 7120-0415-N | Length 55 mm | Withdrawn |
| 7124-0514-N | Angle 24 ° | Withdrawn |
| 7116-1319-N | width(MLxAP), 50 x 22, mm | Withdrawn |
| 7124-2417-N | Width 26 mm | Withdrawn |
| 7116-0319-N | Length 50 mm | Withdrawn |
| 7124-2416-N | Length 55 mm | Withdrawn |
| 7120-1117-N | Length 40 mm | Withdrawn |
| 7120-0420-N | Lordotic Angle – 20 Deg | Withdrawn |
| 7116-1418-N | width(MLxAP), 55 x 22, mm | Withdrawn |
| 7116-1213-N | Height 13 mm | Withdrawn |
| 7116-0315-N | Height 15 mm | Withdrawn |
Showing 250 of 300 catalogue numbers.
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 |
| Base | Nuvasive, Inc. | 462 |
| IDENTITi Nanotec | Alphatec Spine, Inc. | 453 |
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.