Vail OCT Spinal Fixation System
60 catalogue numbers from 7915-4528, listed by Biomet Spine, United States, under Thoracolumbosacral Pedicle Screw System. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
60catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2015-10-24 |
| Record revised | 2025-07-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7915-4528 | SCREW ASSY TURRET TI Ø4.5X28MM | In distribution |
| 7915-3516 | SCREW ASSY TURRET TI Ø3.5X16MM | In distribution |
| 7915-4037 | SCREW ASSY TURRET TI Ø4.0X37MM | In distribution |
| 7915-4046 | SCREW ASSY TURRET TI Ø4.0X46MM | In distribution |
| 7903-6110 | 6.0 OFFSET HOOK LEFT HAND 10MM | In distribution |
| 7915-4531 | SCREW ASSY TURRET TI Ø4.5X31MM | In distribution |
| 7915-3540 | SCREW ASSY TURRET TI Ø3.5X40MM | In distribution |
| 7916-3531 | SCREW ASSY TURRET SMTH SHNK TI Ø3.5X31MM | In distribution |
| 7916-4043 | SCREW ASSY TURRET SMTH SHNK TI Ø4.0X43MM | In distribution |
| 7915-3547 | SCREW ASSY TURRET TI Ø3.5X47MM | In distribution |
| 7915-4042 | SCREW ASSY TURRET TI Ø4.0X42MM | In distribution |
| 7916-4029 | SCREW ASSY TURRET SMTH SHNK TI Ø4.0X29MM | In distribution |
| 7915-4536 | SCREW ASSY TURRET TI Ø4.5X36MM | In distribution |
| 7916-4037 | SCREW ASSY TURRET SMTH SHNK TI Ø4.0X37MM | In distribution |
| 7916-4044 | SCREW ASSY TURRET SMTH SHNK TI Ø4.0X44MM | In distribution |
| 7915-4022 | SCREW ASSY TURRET TI Ø4.0X22MM | In distribution |
| 7915-4519 | SCREW ASSY TURRET TI Ø4.5X19MM | In distribution |
| 7915-3525 | SCREW ASSY TURRET TI Ø3.5X25MM | In distribution |
| 7915-4018 | SCREW ASSY TURRET TI Ø4.0X18MM | In distribution |
| 7915-4535 | SCREW ASSY TURRET TI Ø4.5X35MM | In distribution |
| 7915-4040 | SCREW ASSY TURRET TI Ø4.0X40MM | In distribution |
| 7916-4034 | SCREW ASSY TURRET SMTH SHNK TI Ø4.0X34MM | In distribution |
| 7915-4015 | SCREW ASSY TURRET TI Ø4.0X15MM | In distribution |
| 7915-4036 | SCREW ASSY TURRET TI Ø4.0X36MM | In distribution |
| 7915-4517 | SCREW ASSY TURRET TI Ø4.5X17MM | In distribution |
| 7916-4042 | SCREW ASSY TURRET SMTH SHNK TI Ø4.0X42MM | In distribution |
| 7916-3528 | SCREW ASSY TURRET SMTH SHNK TI Ø3.5X28MM | In distribution |
| 7903-2106 | 4.5 OFFSET HOOK LEFT HAND 6MM | In distribution |
| 7916-3536 | SCREW ASSY TURRET SMTH SHNK TI Ø3.5X36MM | In distribution |
| 7915-3529 | SCREW ASSY TURRET TI Ø3.5X29MM | In distribution |
| 7915-4541 | SCREW ASSY TURRET TI Ø4.5X41MM | In distribution |
| 7915-3539 | SCREW ASSY TURRET TI Ø3.5X39MM | In distribution |
| 7916-3540 | SCREW ASSY TURRET SMTH SHNK TI Ø3.5X40MM | In distribution |
| 7915-4044 | SCREW ASSY TURRET TI Ø4.0X44MM | In distribution |
| 7915-4020 | SCREW ASSY TURRET TI Ø4.0X20MM | In distribution |
| 7916-4031 | SCREW ASSY TURRET SMTH SHNK TI Ø4.0X31MM | In distribution |
| 7915-4024 | SCREW ASSY TURRET TI Ø4.0X24MM | In distribution |
| 7915-4023 | SCREW ASSY TURRET TI Ø4.0X23MM | In distribution |
| 7916-3539 | SCREW ASSY TURRET SMTH SHNK TI Ø3.5X39MM | In distribution |
| 7915-4523 | SCREW ASSY TURRET TI Ø4.5X23MM | In distribution |
| 7915-3533 | SCREW ASSY TURRET TI Ø3.5X33MM | In distribution |
| 7915-3544 | SCREW ASSY TURRET TI Ø3.5X44MM | In distribution |
| 7915-4513 | SCREW ASSY TURRET TI Ø4.5X13MM | In distribution |
| 7916-3535 | SCREW ASSY TURRET SMTH SHNK TI Ø3.5X35MM | In distribution |
| 7903-2208 | 4.5 OFFSET HOOK RIGHT HAND 8MM | In distribution |
| 7915-3522 | SCREW ASSY TURRET TI Ø3.5X22MM | In distribution |
| 7915-4545 | SCREW ASSY TURRET TI Ø4.5X45MM | In distribution |
| 7915-4537 | SCREW ASSY TURRET TI Ø4.5X37MM | In distribution |
| 7916-4032 | SCREW ASSY TURRET SMTH SHNK TI Ø4.0X32MM | In distribution |
| 7915-4544 | SCREW ASSY TURRET TI Ø4.5X44MM | In distribution |
| 7903-6206 | 6.0 OFFSET HOOK RIGHT HAND 6MM | In distribution |
| 7915-3519 | SCREW ASSY TURRET TI Ø3.5X19MM | In distribution |
| 7915-4025 | SCREW ASSY TURRET TI Ø4.0X25MM | In distribution |
| 7915-4033 | SCREW ASSY TURRET TI Ø4.0X33MM | In distribution |
| 7915-3511 | SCREW ASSY TURRET TI Ø3.5X11MM | In distribution |
| 7916-3541 | SCREW ASSY TURRET SMTH SHNK TI Ø3.5X41MM | In distribution |
| 7915-3518 | SCREW ASSY TURRET TI Ø3.5X18MM | In distribution |
| 7915-4547 | SCREW ASSY TURRET TI Ø4.5X47MM | In distribution |
| 7915-4546 | SCREW ASSY TURRET TI Ø4.5X46MM | In distribution |
| 7916-3543 | SCREW ASSY TURRET SMTH SHNK TI Ø3.5X43MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151974 | 2015-11-13 |
| K141804 | 2014-09-25 |
| K121130 | 2012-06-15 |
| K091067 | 2009-07-14 |
| K081952 | 2008-10-07 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-03-12 | Class II | Nonconforming Material/Component | Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification. | 4,765 units | 2015-12-21 |
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.