Zavation Screw
SCREW CORTICAL-CANCELLOUS 6.5 x 105
3manufacturers in China registered for this device type
90catalogue numbers in this listing
1510(k) clearance
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 | Zavation, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K230731 |
| Record published | 2026-05-29 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15-8595 | In distribution | |
| 15-4555 | In distribution | |
| 15-7590 | In distribution | |
| 15-4540 | In distribution | |
| 15-5555 | In distribution | |
| 15-7580 | In distribution | |
| 15-7575 | In distribution | |
| 15-4580 | In distribution | |
| 15-7585 | In distribution | |
| 15-5545 | In distribution | |
| 15-6535 | In distribution | |
| 15-4565 | In distribution | |
| 15-8590 | In distribution | |
| 15-8570 | In distribution | |
| 15-5530 | In distribution | |
| 15-6595 | In distribution | |
| 15-4585 | In distribution | |
| 15-5550 | In distribution | |
| 15-6570 | In distribution | |
| 15-65105 | In distribution | |
| 15-5580 | In distribution | |
| 15-6590 | In distribution | |
| 15-45110 | In distribution | |
| 15-5540 | In distribution | |
| 15-8565 | In distribution | |
| 15-5575 | In distribution | |
| 15-4575 | In distribution | |
| 15-7560 | In distribution | |
| 15-6550 | In distribution | |
| 15-8550 | In distribution | |
| 15-4530 | In distribution | |
| 15-6565 | In distribution | |
| 15-65100 | In distribution | |
| 15-7550 | In distribution | |
| 15-85105 | In distribution | |
| 15-5590 | In distribution | |
| 15-6555 | In distribution | |
| 15-6530 | In distribution | |
| 15-55100 | In distribution | |
| 15-6545 | In distribution | |
| 15-4560 | In distribution | |
| 15-4595 | In distribution | |
| 15-7595 | In distribution | |
| 15-4525 | In distribution | |
| 15-8560 | In distribution | |
| 15-5525 | In distribution | |
| 15-6560 | In distribution | |
| 15-65110 | In distribution | |
| 15-7565 | In distribution | |
| 15-4590 | In distribution | |
| 15-7555 | In distribution | |
| 15-8530 | In distribution | |
| 15-75100 | In distribution | |
| 15-5535 | In distribution | |
| 15-6580 | In distribution | |
| 15-8580 | In distribution | |
| 15-7530 | In distribution | |
| 15-8540 | In distribution | |
| 15-5585 | In distribution | |
| 15-55110 | In distribution | |
| 15-7540 | In distribution | |
| 15-55105 | In distribution | |
| 15-4550 | In distribution | |
| 15-7570 | In distribution | |
| 15-7545 | In distribution | |
| 15-5570 | In distribution | |
| 15-4545 | In distribution | |
| 15-8535 | In distribution | |
| 15-5595 | In distribution | |
| 15-45105 | In distribution | |
| 15-75110 | In distribution | |
| 15-8585 | In distribution | |
| 15-6585 | In distribution | |
| 15-4570 | In distribution | |
| 15-8555 | In distribution | |
| 15-4535 | In distribution | |
| 15-8575 | In distribution | |
| 15-7525 | In distribution | |
| 15-85110 | In distribution | |
| 15-6525 | In distribution | |
| 15-6575 | In distribution | |
| 15-85100 | In distribution | |
| 15-8525 | In distribution | |
| 15-5560 | In distribution | |
| 15-5565 | In distribution | |
| 15-45100 | In distribution | |
| 15-7535 | In distribution | |
| 15-75105 | In distribution | |
| 15-6540 | In distribution | |
| 15-8545 | In distribution |
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 |
|---|---|
| K142271 | 2014-12-19 |
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.