Endoskeleton® TCS nanoLOCK® Surface Technology
Interbody Fusion Device Parallel Medium 12mm
5manufacturers in China registered for this device type
12catalogue numbers in this listing
4510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Titan Spine, LLC, United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K141953 |
| Record published | 2016-12-15 |
| Record revised | 2025-07-14 (version 9) |
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 | Width 14 to 18 mm; depth 12 to 16 mm; height 5 to 12 mm |
| Distribution end date | 2020-09-18 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5340-1209-N | Width 14 mm | Withdrawn |
| 5360-1409-N | width(MLxAP), 16 x 14, mm | Withdrawn |
| 5360-1412-N | Depth 14 mm | Withdrawn |
| 5340-1207-N | Depth 12 mm | Withdrawn |
| 5340-1212-N | Width 14 mm | Withdrawn |
| 5380-1609-N | Width 18 mm | Withdrawn |
| 5340-1211-N | width(MLxAP), 14 x 12, mm | Withdrawn |
| 5380-1607-N | width(MLxAP), 18 x 16, mm | Withdrawn |
| 5380-1606-N | width(MLxAP), 18 x 16, mm | Withdrawn |
| 5360-1410-N | Depth 14 mm | Withdrawn |
| 5380-1610-N | Depth 16 mm | Withdrawn |
| 5340-1205-N | Width 14 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191565 | 2019-08-06 |
| K153122 | 2015-12-14 |
| K151596 | 2015-10-09 |
| K142940 | 2015-01-28 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Titan Spine, LLC | 510(k) number | 2015-07-20 | Class II | Nonconforming Material/Component | Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not ‘locking’. | 137 units | 2015-10-20 |
| Titan Spine, LLC | 510(k) number | 2015-02-20 | Class II | Nonconforming Material/Component | The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6 Drive | 26 | 2015-04-17 |
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.