Complete Cervical
Screw - Self-Drilling - 3.5x15mm
5manufacturers in China registered for this device type
70catalogue numbers in this listing
8510(k) clearances naming this product 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 | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K102323 |
| Record published | 2015-09-24 |
| Record revised | 2025-10-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2016-09-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 27-13-4017 | 4.0x17mm | In distribution |
| 27-13-3512 | 3.5x12mm | In distribution |
| 27-14-3516 | 3.5x16mm | In distribution |
| 27-10-1808 | 18x15x8mm – 6 deg | In distribution |
| 27-12-3512 | 3.5x12mm | In distribution |
| 27-10-1612 | 16x14x12mm – 6 deg | In distribution |
| 27-13-3515 | 3.5x15mm | In distribution |
| 27-10-1609 | 16x14x9mm – 6 deg | In distribution |
| 27-14-3518 | 3.5x18mm | In distribution |
| 27-14-3512 | 3.5x12mm | In distribution |
| 27-14-4013 | 4.0x13mm | In distribution |
| 27-13-4013 | 4.0x13mm | In distribution |
| 27-13-3516 | 3.5x16mm | In distribution |
| 27-14-3513 | 3.5x13mm | In distribution |
| 27-10-1608 | 16x14x8mm – 6 deg | In distribution |
| 27-13-4015 | 4.0x15mm | In distribution |
| 27-10-1812 | 18x15x12mm – 6 deg | In distribution |
| 27-10-1811 | 18x15x11mm – 6 deg | In distribution |
| 27-14-4019 | 4.0x19mm | In distribution |
| 27-14-3514 | 3.5x14mm | In distribution |
| 27-10-1806 | 18x15x6mm – 6 deg | In distribution |
| 27-10-1611 | 16x14x11mm – 6 deg | In distribution |
| 27-10-1606 | 16x14x6mm – 6 deg | In distribution |
| 27-10-1607 | 16x14x7mm – 6 deg | In distribution |
| 27-13-3518 | 3.5x18mm | In distribution |
| 27-10-1610 | 16x14x10mm – 6 deg | In distribution |
| 27-13-3514 | 3.5x14mm | In distribution |
| 27-13-4019 | 4.0x19mm | In distribution |
| 27-10-1807 | 18x15x7mm – 6 deg | In distribution |
| 27-14-4015 | 4.0x15mm | In distribution |
| 27-10-1809 | 18x15x9mm – 6 deg | In distribution |
| 27-14-4017 | 4.0x17mm | In distribution |
| 27-11-4011 | 4.0x11mm | Withdrawn |
| 27-12-3515 | 3.5x15mm | Withdrawn |
| 27-12-3518 | 3.5x18mm | Withdrawn |
| 27-12-4019 | 4.0x19mm | Withdrawn |
| 27-12-3510 | 3.5x10mm | Withdrawn |
| 27-14-4011 | 4.0x11mm | Withdrawn |
| 27-14-3511 | 3.5x11mm | Withdrawn |
| 27-13-3511 | 3.5x11mm | Withdrawn |
| 27-11-4019 | 4.0x19mm | Withdrawn |
| 27-11-3515 | 3.5x15mm | Withdrawn |
| 27-12-3517 | 3.5x17mm | Withdrawn |
| 27-12-3516 | 3.5x16mm | Withdrawn |
| 27-14-3510 | 3.5x10mm | Withdrawn |
| 27-10-1810 | 18x15x10mm – 6 deg | Withdrawn |
| 27-11-3517 | 3.5x17mm | Withdrawn |
| 27-12-4011 | 4.0x11mm | Withdrawn |
| 27-12-3513 | 3.5x13mm | Withdrawn |
| 27-12-4015 | 4.0x15mm | Withdrawn |
| 27-11-4017 | 4.0x17mm | Withdrawn |
| 27-13-3513 | 3.5x13mm | Withdrawn |
| 27-11-4015 | 4.0x15mm | Withdrawn |
| 27-12-4013 | 4.0x13mm | Withdrawn |
| 27-11-4013 | 4.0x13mm | Withdrawn |
| 27-13-3517 | 3.5x17mm | Withdrawn |
| 27-11-3516 | 3.5x16mm | Withdrawn |
| 27-11-3511 | 3.5x11mm | Withdrawn |
| 27-11-3514 | 3.5x14mm | Withdrawn |
| 27-13-4011 | 4.0x11mm | Withdrawn |
| 27-14-3515 | 3.5x15mm | Withdrawn |
| 27-11-3512 | 3.5x12mm | Withdrawn |
| 27-12-3511 | 3.5x11mm | Withdrawn |
| 27-11-3513 | 3.5x13mm | Withdrawn |
| 27-13-3510 | 3.5x10mm | Withdrawn |
| 27-11-3518 | 3.5x18mm | Withdrawn |
| 27-11-3510 | 3.5x10mm | Withdrawn |
| 27-12-3514 | 3.5x14mm | Withdrawn |
| 27-14-3517 | 3.5x17mm | Withdrawn |
| 27-12-4017 | 4.0x17mm | 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 |
|---|---|
| K233414 | 2023-11-28 |
| K212904 | 2021-12-14 |
| K213359 | 2021-12-09 |
| K201073 | 2020-09-18 |
| K201646 | 2020-09-14 |
| K190655 | 2019-04-29 |
| K170569 | 2017-06-15 |
| K161081 | 2016-09-14 |
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.