Spine System
61 catalogue numbers from 14-501310, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
61catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2015-10-24 |
| Record revised | 2025-07-02 (version 7) |
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 |
|---|---|---|
| 14-501310 | 7.5MM(D) X 60MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 14-501335 | 8.5MM(D) X 85MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 14-501167 | NARROW REDUCED LAMINAR HOOK LARGE | In distribution |
| 6851 | DOUBLE ROD FIXATION WASHER MEDIUM – LEFT | In distribution |
| 6110MP | VLS SCREW W/ FLUTES – 6.35 6.5MM DIA X 30MM LGTH | In distribution |
| 6552MP | VLS SCREW W/FLUTES-6.35MM 4.0MM X 30MM TI | In distribution |
| 6108MP | VLS SCREW W/ FLUTES – 6.35 5.5MM DIA X 45MM LGTH | In distribution |
| 6113MP | VLS SCREW W/ FLUTES – 6.35 6.5MM DIA X 45MM LGTH | In distribution |
| 6956 | LARGE, CROSS CONNECTOR | In distribution |
| 14-500777 | DOMINO, SS 4.75MM X 5.5MM AXIAL | In distribution |
| 14-501329 | 8.5MM(D) X 55MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 14-501336 | 8.5MM(D) X 90MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 6587M | MULTI-AXIAL SCREW (TI) 8.0MM (D) X 60MM (L) W/COLLAR | In distribution |
| 6438 | 6.35MM X 8CM TI ALLOY CURVED ROD | In distribution |
| 6436 | 6.35MM X 6CM TI ALLOY CURVED ROD | In distribution |
| 6954 | SMALL, CROSS CONNECTOR | In distribution |
| 6112M | MULTI-AXIAL SCREW (TI) 6.5MM (D) X 40MM (L) W/COLLAR | In distribution |
| 14-501330 | 8.5MM(D) X 60MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 07.00017.701 | Hex Driver Sleeve | In distribution |
| 6111M | MULTI-AXIAL SCREW (TI) 6.5MM (D) X 35MM (L) W/COLLAR | In distribution |
| LV01484 | Ø2.4mm Pilot Drill with Stop | In distribution |
| 6800MP | VLS SCREW W/FLUTE-6.35 6.5MM X 55MM TI | In distribution |
| 14-501175 | ANGLED BLADE HOOK, MEDIUM | In distribution |
| 6111MP | VLS SCREW W/ FLUTES – 6.35 6.5MM DIA X 35MM LGTH | In distribution |
| 14-501163 | NARROW LAMINAR HOOK, MEDIUM | In distribution |
| 6119MP | VLS SCREW W/ FLUTES – 6.35 7.0MM DIA X 50MM LGTH | In distribution |
| 6109MP | VLS SCREW W/ FLUTES – 6.35 5.5MM DIA X 50MM LGTH | In distribution |
| 14-501318 | 7.5MM(D) X 100MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 6109M | MULTI-AXIAL SCREW (TI) 5.5MM (D) X 50MM (L) W/COLLAR | In distribution |
| 14-513170R | 4.0MM X 70MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-501322 | 8.5MM(D) X 20MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 6115MP | VLS SCREW W/ FLUTES – 6.35 7.0MM DIA X 30MM LGTH | In distribution |
| 6585M | MULTI-AXIAL SCREW (TI) 8.0MM (D) X 50(L) W/COLLAR | In distribution |
| 6588M | MULTI-AXIAL SCREW (TI) 8.0MM (D) X 70MM (L) W/COLLAR | In distribution |
| 14-501325 | 8.5MM(D) X 35MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 6439 | 6.35MM X 9CM TI ALLOY CURVED ROD | In distribution |
| 14-575615 | WASHER ANTERIOR, SST POLARIS LARGE | In distribution |
| 6112MP | VLS SCREW W/ FLUTES – 6.35 6.5MM DIA X 40MM LGTH | In distribution |
| 6110M | MULTI-AXIAL SCREW (TI) 6.5MM (D) X 30MM (L) W/COLLAR | In distribution |
| 6105MP | VLS SCREW W/FLUTES- 6.35 5.5MM DIA X 30MM LGTH | In distribution |
| 6801M | MULTI-AXIAL SCREW (TI) 7.0MM(D) X 55MM(L) W/COLLAR | In distribution |
| 6422 | PRE-CURVED CP TI ROD 50MM 6.35MM DIA | In distribution |
| 6550MP | VLS SCREW W/FLUTES- 6.35MM 4.0MM X 20MM TI | In distribution |
| 6107MP | VLS SCREW W/ FLUTES – 6.35 5.5MM DIA X 40MM LGTH | In distribution |
| 6423 | PRE-CURVED CP TI ROD 60MM 6.35MM DIA | In distribution |
| 6106MP | VLS SCREW W/FLUTES – 6.35 5.5MM DIA X 35MM LGTH | In distribution |
| 6118MP | VLS SCREW W/ FLUTES – 6.35 7.0MM DIA X 45MM LGTH | In distribution |
| 14-501173 | RIGHT OFFSET HOOK, LARGE | In distribution |
| 14-501155 | LEFT ANGLED HOOK, LARGE | In distribution |
| 14-501151 | PEDICLE HOOK, MEDIUM | In distribution |
| LV01487 | 35mm Pilot Drill Depth Stop | In distribution |
| 6114MP | VLS SCREW W/ FLUTES – 6.35 6.5MM DIA X 50MM LGTH | In distribution |
| 6116MP | VLS SCREW W/ FLUTES – 6.35 7.0MM DIA X 35MM LGTH | In distribution |
| 6117MP | VLS SCREW W/ FLUTES – 6.35 7.0MM DIA X 40MM LGTH | In distribution |
| 14-501170 | LEFT OFFSET HOOK, LARGE | In distribution |
| 6857 | DOUBLE ROD FIXATION WASHER LARGE – RIGHT | In distribution |
| 14-501303 | 7.5MM(D) X 25MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 6872 | WASHER – LARGE | In distribution |
| 6853 | DOUBLE ROD FIXATION WASHER X-LARGE – LEFT | In distribution |
| 1100-3016B | FIXED CANCELLOUS BONE SCREW BLUNT TIP, 4.0MM(D) X 16MM(L) | In distribution |
| 6117M | MULTI-AXIAL SCREW (TI) 7.0MM (D) X 40MM (L) W/COLLAR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103393 | 2011-02-02 |
| K080646 | 2008-05-02 |
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.