Spine System
61 catalogue numbers from 1200-1212, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
61catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Record published | 2017-10-27 |
| 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 |
|---|---|---|
| 1200-1212 | STRAIGHT CROSS CONNECTOR | In distribution |
| 1200-1202 | ARCHED CROSS CONNECTOR | In distribution |
| 6450 | POLARIS TI 6.35MM SEAT VLS OPEN | In distribution |
| 6007 | 80MM STRAIGHT CP TI ROD 6.35MM DIA X 8CM LGTH | In distribution |
| 6010 | 140MM STRAIGHT CP TI ROD 6.35MM DIA X 14CM LGTH | In distribution |
| 6873 | WASHER X-LARGE | In distribution |
| 1200-1216 | STRAIGHT CROSS CONNECTOR | In distribution |
| 6945 | HF INTEGRAL SCREW-6.35 8.0MM X 50MM TI | In distribution |
| 1200-1215 | STRAIGHT CROSS CONNECTOR | In distribution |
| 6116M | MULTI-AXIAL SCREW (TI) 7.0MM (D) X 35MM (L) W/COLLAR | In distribution |
| 6037 | 60CM TI ALLOY ROD (TI) | In distribution |
| 6602 | TAPER POINT EXTERNAL HEX SET SCREW (TI) | In distribution |
| 1200-1206 | ARCHED CROSS CONNECTOR | In distribution |
| 14-500784 | 6.0MM X 6.35MM AXIAL SST DOMINO | In distribution |
| 6440 | 6.35MM X 10CM TI ALLOY CURVED ROD | In distribution |
| 6955 | MEDIUM, CROSS CONNECTOR | In distribution |
| 14-500771 | 4.5MM X 4.5MM AXIAL SST DOMINO | In distribution |
| 1200-1214 | STRAIGHT CROSS CONNECTOR | In distribution |
| 1200-1210 | STRAIGHT CROSS CONNECTOR | In distribution |
| 6553MP | VLS SCREW W/FLUTES-6.35MM 4.0MM X 35MM TI | In distribution |
| LV01490 | 50mm Pilot Drill Depth Stop | In distribution |
| 6008 | 100MM STRAIGHT CP TI ROD 6.35MM DIA X 10CM LGTH | In distribution |
| 6113M | MULTI-AXIAL SCREW (TI) 6.5MM (D) X 45MM (L) W/COLLAR | In distribution |
| 6306 | SYNERGY TI 6.35MM CLAMP ADJ TRANSVERSE CONNECTOR | In distribution |
| 1200-1213 | STRAIGHT CROSS CONNECTOR | In distribution |
| LV00846 | SHARP LINEUM 3.5MM TAP LINEUM | In distribution |
| 6948 | HF INTEGRAL SCREW-6.35 8.0MM X 70MM TI | In distribution |
| 1200-1230 | STRAIGHT CROSS CONNECTOR | In distribution |
| 6942 | HF INTEGRAL SCREW-6.35 8.0MM X 35MM TI | In distribution |
| 6650 | XS, CROSS CONNECTOR | In distribution |
| 6800M | MULTI-AXIAL SCREW (TI) 6.5MM(D) X 55MM(L) W/COLLAR | In distribution |
| 6801MP | VLS SCREW W/FLUTES-6.35 7.0MM X 55MM TI | In distribution |
| 6871 | WASHER – MEDIUM | In distribution |
| 6433 | 6.35MM X 3CM TI ALLOY CURVED ROD | In distribution |
| LV00933 | LINEUM INLINE COUNTER TORQUE | In distribution |
| 14-575124 | LATERAL CONNECTOR, OPEN, 50MM 6.35 SST | In distribution |
| 6850 | DOUBLE ROD FIXATION WASHER SMALL – LEFT | In distribution |
| 6852 | DOUBLE ROD FIXATION WASHER LARGE – LEFT | In distribution |
| 5000915 | 4.0 MM X 14 MM SELF-DRILLING CYPRUS ANTERIOR CERV PLATE SYS | In distribution |
| 6947 | HF INTEGRAL SCREW-6.35 8.0MM X 60MM TI | In distribution |
| 14-501156 | RIGHT ANGLED HOOK, SMALL | In distribution |
| 6807MP | VLS SCREW W/FLUTES-6.35 4.75MM X 40MM TI | In distribution |
| 14-500778 | 4.75MM X 6.0MM AXIAL SST DOMINO | In distribution |
| 14-500773 | 4.5MM X 5.5MM AXIAL SST DOMINO | In distribution |
| 6944 | HF INTEGRAL SCREW-6.35 8.0MM X 45MM TI | In distribution |
| 6554MP | VLS SCREW W/FLUTES- 6.35MM 4.0MM X 40MM TI | In distribution |
| 1200-1211 | STRAIGHT CROSS CONNECTOR | In distribution |
| 14-501290 | 6.5MM(D) X 60MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 6855 | DOUBLE ROD FIXATION WASHER SMALL – RIGHT | In distribution |
| 6434 | 6.35MM X 4CM TI ALLOY CURVED ROD | In distribution |
| 1200-1231 | STRAIGHT CROSS CONNECTOR | In distribution |
| LV01055 | LARGE HANDLE OCC. SCREW DRIVER LINEUM | In distribution |
| 6036 | STRAIGHT TI ALLOY ROD 480MM | In distribution |
| 6420 | PRE-CURVED CP TI ROD 30MM 6.35MM DIA | In distribution |
| 6301 | LATERAL CONNECTOR (TI) (5.5MM / 6.35MM) | In distribution |
| 6870 | WASHER – SMALL | In distribution |
| 1200-1204 | ARCHED CROSS CONNECTOR | In distribution |
| 6860 | FIXATION WASHER – SMALL | In distribution |
| 14-501171 | RIGHT OFFSET HOOK, SMALL | In distribution |
| 14-500776 | DOMINO, SS 4.75MMX4.75MM AXIAL | In distribution |
| 6106M | MULTI-AXIAL SCREW (TI) 5.5MM (D) X 35MM (L) W/COLLAR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071377 | 2007-08-06 |
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.