Everest® Spinal System
Locking Screw Inserter XTower, Cannulated Size XTower, Cannulated
53manufacturers in China registered for this device type
660catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument
Record
| Listed by | VB Spine LLC |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2021-08-06 |
| Record revised | 2026-04-20 (version 7) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 1.3 to 20 mm; length 20 to 399.5 mm; width 3 to 17.4 mm; lumen/inner diameter 14.4 to 17.3 mm; angle 90 ° |
| Distribution end date | 2025-09-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRO-1094-07 | In distribution | |
| 5101-90014 | In distribution | |
| 2901-90029 | In distribution | |
| K2-29-2029-01 | In distribution | |
| SP-2361 | In distribution | |
| 2901-90110-03 | In distribution | |
| 5101-90264 | In distribution | |
| 2901-90052 | In distribution | |
| 5101-90252 | In distribution | |
| PRO-1226-02 | In distribution | |
| 5101-90195 | In distribution | |
| SP-4201-02 | Outer Diameter 15 mm | In distribution |
| PRO-1391-05 | Outer Diameter 5 mm | In distribution |
| SP-3146-04 | Outer Diameter 9.5 mm | In distribution |
| PRO-1201-02 | Length 288 mm | In distribution |
| 2901-90096 | In distribution | |
| PRO-1129-02 | Outer Diameter 5.5 mm | In distribution |
| PRO-1004-01 | Outer Diameter 3.5 mm | In distribution |
| 2901-90031 | In distribution | |
| PRO-1104 | In distribution | |
| SP-3146-09 | Outer Diameter 4 mm | In distribution |
| SP-1820-03 | Outer Diameter 1.3 mm | In distribution |
| 2901-90051 | In distribution | |
| 2901-90141 | In distribution | |
| SP-4253-04 | In distribution | |
| 2901-90098 | In distribution | |
| 2901-90095 | In distribution | |
| K2-28-2002-05 | In distribution | |
| K2-29-2001-02 | In distribution | |
| 2901-90172 | In distribution | |
| 2901-90133 | In distribution | |
| PRO-1257 | In distribution | |
| 2901-90071 | In distribution | |
| PRO-1405 | In distribution | |
| PRO-1094-04 | In distribution | |
| 5101-90037 | In distribution | |
| 2901-90016 | In distribution | |
| PRO-1094-01 | Width 3 mm | In distribution |
| SP-4201-03 | Outer Diameter 20 mm | In distribution |
| SP-4227-04 | In distribution | |
| SP-3146-12 | Outer Diameter 6.5 mm | In distribution |
| 5101-90179 | In distribution | |
| K2-29-2013-01 | In distribution | |
| SP-3146-13 | Outer Diameter 7.5 mm | In distribution |
| 5101-90180 | In distribution | |
| PRO-1391-08 | Outer Diameter 6.5 mm | In distribution |
| SP-1820-01 | Outer Diameter 1.4 mm | In distribution |
| PRO-1183-03 | In distribution | |
| 2901-90209 | In distribution | |
| SP-4143 | Size 25 Hexalobe | In distribution |
| SP-4082 | In distribution | |
| PRO-1171-01 | In distribution | |
| 5101-90176-G1 | In distribution | |
| PRO-1399-04 | Outer Diameter 6.5 mm | In distribution |
| SP-4004-02 | In distribution | |
| PRO-1392-01 | In distribution | |
| 2901-90079 | In distribution | |
| 2901-90067 | In distribution | |
| 5101-90278-G1 | In distribution | |
| SP-3171 | In distribution | |
| SP-4254 | In distribution | |
| 5101-90255 | In distribution | |
| 2901-90241 | In distribution | |
| 5101-90230 | In distribution | |
| SP-4146-02 | In distribution | |
| 2901-90013 | In distribution | |
| PRO-1004-05 | Outer Diameter 7.5 mm | In distribution |
| PRO-1399-06 | Outer Diameter 8.5 mm | In distribution |
| PRO-1258 | In distribution | |
| K2-29-2009-01 | In distribution | |
| PRO-1326-04 | Outer Diameter 6.5 mm | In distribution |
| 2901-90050 | In distribution | |
| SP-3169 | In distribution | |
| 2901-90065 | In distribution | |
| SP-4184 | In distribution | |
| PRO-1140-03 | Outer Diameter 5.5 mm | In distribution |
| 5101-90245 | In distribution | |
| SP-2432-04 | Outer Diameter 6.5 mm | In distribution |
| 5101-90117 | In distribution | |
| 2901-90213 | In distribution | |
| 5101-90167 | In distribution | |
| 5101-90219 | In distribution | |
| SP-3146-07 | Outer Diameter 4.5 mm | In distribution |
| SP-4157-02 | Size 20 Hexalobe | In distribution |
| SP-1731-04 | In distribution | |
| 5101-90267 | In distribution | |
| 2901-90110 | In distribution | |
| 2901-90214 | In distribution | |
| 2901-90093 | In distribution | |
| 5101-90125 | In distribution | |
| 2901-90123 | In distribution | |
| 2901-90111 | In distribution | |
| 5101-90177 | In distribution | |
| 2901-90239 | In distribution | |
| 5101-90107 | In distribution | |
| SP-3076-04 | Length 399.5 mm | In distribution |
| 2801-90008 | In distribution | |
| PRO-1391-10 | Outer Diameter 7.5 mm | In distribution |
| K2-51-2095-06 | In distribution | |
| SP-4148-02 | Length 209 mm | In distribution |
| SP-3226 | In distribution | |
| PRO-1288 | In distribution | |
| SP-1820-04 | Outer Diameter 1.3 mm | In distribution |
| 2901-90068 | In distribution | |
| PRO-1398 | In distribution | |
| 5001-90009-G1 | In distribution | |
| 5101-90266 | In distribution | |
| PRO-1140-06 | Outer Diameter 8.5 mm | In distribution |
| PRO-1359 | In distribution | |
| 2901-90210 | In distribution | |
| 2901-90143 | In distribution | |
| 5101-90091 | In distribution | |
| PRO-1210-01 | In distribution | |
| 5101-90204 | In distribution | |
| 2901-90089 | In distribution | |
| 5101-90159 | In distribution | |
| 5101-90170 | In distribution | |
| SP-3146-05 | Outer Diameter 10.5 mm | In distribution |
| 5101-90184 | In distribution | |
| SP-1450-01 | In distribution | |
| 5101-90153 | In distribution | |
| 2901-90019 | In distribution | |
| SP-4201-01 | Outer Diameter 10 mm | In distribution |
| PRO-1095-02 | Outer Diameter 5.5 mm | In distribution |
| 5101-90126 | In distribution | |
| 5101-90026 | In distribution | |
| 5101-90131 | In distribution | |
| PRO-1084 | In distribution | |
| 5101-90106 | In distribution | |
| PRO-1190-03 | In distribution | |
| 2901-90044 | In distribution | |
| 2901-90240 | In distribution | |
| SP-3146-11 | Outer Diameter 5.5 mm | In distribution |
| 2901-90169 | In distribution | |
| SP-2240-01 | Size 30 Hexalobe | In distribution |
| SP-4140 | In distribution | |
| SP-2158 | In distribution | |
| 5101-90021-SG | In distribution | |
| SP-3208 | In distribution | |
| PRO-1213-02 | Length 200 mm | In distribution |
| PRO-1226-01 | In distribution | |
| 5101-90265 | In distribution | |
| 5101-90021 | In distribution | |
| PRO-1420 | In distribution | |
| K2-29-2032-01 | In distribution | |
| K2-29-2025-01 | In distribution | |
| PRO-1399-02 | Outer Diameter 4.5 mm | In distribution |
| 2901-90101 | In distribution | |
| SP-1547-03 | Outer Diameter 7.5 mm | In distribution |
| 5101-90164 | In distribution | |
| SP-4154-01 | In distribution | |
| PRO-1196-02 | In distribution | |
| K2-29-2065-02 | In distribution | |
| SP-4023 | In distribution | |
| 5101-90124 | In distribution | |
| PRO-1254-01 | In distribution | |
| 5101-90285-G1 | In distribution | |
| 2901-90030 | In distribution | |
| 2901-90027 | In distribution | |
| 5101-90012 | In distribution | |
| PRO-1067-04 | Outer Diameter 6.5 mm | In distribution |
| 5101-90234 | In distribution | |
| PRO-1004-07 | Outer Diameter 9.5 mm | In distribution |
| SP-4078-01 | Outer Diameter 3.5 mm | In distribution |
| PRO-1333-02 | In distribution | |
| K2-29-2008-01 | In distribution | |
| 5101-90250 | In distribution | |
| PRO-1334 | In distribution | |
| 2901-90041 | In distribution | |
| PRO-1391-01 | Outer Diameter 3 mm | In distribution |
| PRO-1395 | In distribution | |
| PRO-1378 | In distribution | |
| PRO-1171-02 | In distribution | |
| SP-4227-01 | In distribution | |
| SP-4200-02 | Length 264.2 mm | In distribution |
| 2901-90040 | In distribution | |
| 5101-90067 | In distribution | |
| 2901-90026 | In distribution | |
| 5101-90253 | In distribution | |
| SP-4181-05 | Width 17.4 mm | In distribution |
| 5101-90192 | In distribution | |
| 2901-90181 | In distribution | |
| K2-28-2000-02 | In distribution | |
| SP-4148-03 | Length 140 mm | In distribution |
| SP-3146-02 | Outer Diameter 7.5 mm | In distribution |
| SP-1983 | In distribution | |
| 5101-90132 | In distribution | |
| 2901-N90006 | In distribution | |
| PRO-1201-01 | Length 238 mm | In distribution |
| PRO-1326-05 | Outer Diameter 7.5 mm | In distribution |
| SP-1945-03 | Length 140 mm | In distribution |
| 2901-90066 | In distribution | |
| 5101-90016 | In distribution | |
| 2901-90012 | In distribution | |
| SP-1731-03 | In distribution | |
| SP-2090 | In distribution | |
| 5101-90122 | In distribution | |
| 2901-90168 | In distribution | |
| 5101-90051 | In distribution | |
| PRO-1341 | In distribution | |
| PRO-1106 | In distribution | |
| 2901-N90045 | In distribution | |
| K2-29-2033-01 | In distribution | |
| SP-2317-01 | Length 121 mm | In distribution |
| SP-3146-03 | Outer Diameter 8.5 mm | In distribution |
| 2901-90034 | In distribution | |
| PRO-1259 | In distribution | |
| PRO-1210-02 | In distribution | |
| SP-4181-02 | Width 16.5 mm | In distribution |
| K2-29-2035-01 | In distribution | |
| SP-4226-01 | Size 30 Hexalobe | In distribution |
| SP-1945-01 | Length 279 mm | In distribution |
| 5001-90007 | In distribution | |
| SP-4226-02 | Size 30 Hexalobe | In distribution |
| SP-4116 | In distribution | |
| SP-2316-01 | In distribution | |
| K2-29-2006-01 | In distribution | |
| 5101-90221 | In distribution | |
| PRO-1094-06 | In distribution | |
| PRO-1391-04 | Outer Diameter 4.5 mm | In distribution |
| 2801-90000 | In distribution | |
| SP-3241-02 | In distribution | |
| 2901-90238 | In distribution | |
| SP-3076-01 | Length 303.8 mm | In distribution |
| PRO-1391-02 | Outer Diameter 3.5 mm | In distribution |
| PRO-1399-03 | Outer Diameter 5.5 mm | In distribution |
| SP-4181-03 | Width 17.4 mm | In distribution |
| PRO-1067-05 | Outer Diameter 7.5 mm | In distribution |
| PRO-1140-04 | Outer Diameter 6.5 mm | In distribution |
| 5101-90283-G1 | In distribution | |
| PRO-1423 | In distribution | |
| 2901-90132 | In distribution | |
| SP-4142 | Size 30 Hexalobe | In distribution |
| PRO-1326-02 | Outer Diameter 4.5 mm | In distribution |
| PRO-1196-04 | In distribution | |
| K2-29-2030-01 | In distribution | |
| 5101-90004 | Outer Diameter 5.5 mm | In distribution |
| PRO-1001 | In distribution | |
| SP-4246 | In distribution | |
| PRO-1196-01 | In distribution | |
| SP-4200-03 | Length 282.2 mm | In distribution |
| 5101-90181 | In distribution | |
| 2901-90046 | In distribution | |
| SP-3209 | In distribution | |
| SP-4012 | In distribution | |
| SP-4188 | In distribution | |
| 5101-90100 | In distribution | |
| 2901-90076 | In distribution | |
| PRO-1352 | In distribution | |
| 5101-90189 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Razek Equipamentos | Razek Equipamentos Ltda | 11,578 |
| Orthopedic Manual Surgical Instrument | Globus Medical, Inc. | 4,784 |
| Instrument | Howmedica Osteonics Corp | 4,539 |
| Orthopedic Manual Surgical Instrument | Ortho Development Corp. | 4,076 |
| Knee Instruments | Medacta International SA | 3,944 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 3,420 |
| Arthrex® | Arthrex, Inc. | 3,106 |
| Spine Instruments | Medacta International SA | 2,892 |
| Orthopedic Manual Surgical Instrument | Medtronic Sofamor Danek, Inc. | 2,766 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| K2M, Inc. | UDI-DI | 2022-01-13 | Class II | Process control | Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be aff | 686 Total Devices | |
| K2M, Inc. | UDI-DI | 2022-01-13 | Class II | Process control | Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be aff | 686 Total Devices | |
| K2M, Inc. | UDI-DI | 2020-11-04 | Class II | Process change control | All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks | 197 units | 2024-02-22 |
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.