Tailored-H
TAILORED-H 3DTI INTEGRATED IMPLANT - 16x18x10MM - 12°
5manufacturers in China registered for this device type
58catalogue numbers in this listing
1510(k) clearance
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 | Bespoke Technologies, United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Premarket notification | Exempt |
| Record published | 2025-03-24 |
| Record revised | 2025-09-10 (version 3) |
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 |
| Distribution end date | 2025-08-25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BCS-002-07 | Withdrawn | |
| BCSD-4012 | Withdrawn | |
| BCS7-1416-9 | Withdrawn | |
| BCS12-1618-7 | Withdrawn | |
| BCS12-1518-9 | Withdrawn | |
| BCSD-4014 | Withdrawn | |
| BCSD-4212 | Withdrawn | |
| BCS-002-11 | Withdrawn | |
| BCS12-1618-10 | Withdrawn | |
| BCS7-1416-10 | Withdrawn | |
| BCS7-1518-9 | Withdrawn | |
| BCS12-1518-10 | Withdrawn | |
| BCSD-4218 | Withdrawn | |
| BCS7-1518-6 | Withdrawn | |
| BCS-003-12 | Withdrawn | |
| BCS7-1518-8 | Withdrawn | |
| BCS7-1518-10 | Withdrawn | |
| BCSL-001 | Withdrawn | |
| BCS12-1618-8 | Withdrawn | |
| BCS7-1618-9 | Withdrawn | |
| BCSD-3516 | Withdrawn | |
| BCS12-1518-6 | Withdrawn | |
| BCS7-1416-7 | Withdrawn | |
| BCS12-1416-6 | Withdrawn | |
| BCSD-4216 | Withdrawn | |
| BCS12-1416-9 | Withdrawn | |
| BCS12-1416-7 | Withdrawn | |
| BCSD-4016 | Withdrawn | |
| BCS-003-09 | Withdrawn | |
| BCS7-1618-6 | Withdrawn | |
| BCS-003-10 | Withdrawn | |
| BCS-003-11 | Withdrawn | |
| BCS12-1518-8 | Withdrawn | |
| BCS-003-06 | Withdrawn | |
| BCSD-4018 | Withdrawn | |
| BCS7-1618-7 | Withdrawn | |
| BCS7-1416-8 | Withdrawn | |
| BCS7-1518-7 | Withdrawn | |
| BCS-001 | Withdrawn | |
| BCS7-1416-6 | Withdrawn | |
| BCS12-1416-8 | Withdrawn | |
| BCS12-1618-9 | Withdrawn | |
| BCS-002-08 | Withdrawn | |
| BCSD-3518 | Withdrawn | |
| BCS-002-10 | Withdrawn | |
| BCSD-3514 | Withdrawn | |
| BCS-003-07 | Withdrawn | |
| BCS7-1618-10 | Withdrawn | |
| BCS-002-12 | Withdrawn | |
| BCSD-3512 | Withdrawn | |
| BCS12-1416-10 | Withdrawn | |
| BCS-003-08 | Withdrawn | |
| BCS7-1618-8 | Withdrawn | |
| BCS12-1618-6 | Withdrawn | |
| BCS-002-06 | Withdrawn | |
| BCS12-1518-7 | Withdrawn | |
| BCS-002-09 | Withdrawn | |
| BCSD-4214 | 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 |
|---|---|
| K222903 | 2022-11-18 |
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.