Centurion
3.5MM/ 5.5MM Transition ROD, Cocr, 200MM/ 300MM
4manufacturers in China registered for this device type
175catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Orthofix US LLC, United States |
|---|---|
| FDA product code | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K180025 |
| Record published | 2019-03-12 |
| Record revised | 2026-02-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 69-2142 | In distribution | |
| 69-3422 | In distribution | |
| 69-3334 | In distribution | |
| 69-3450 | In distribution | |
| 69-3434 | In distribution | |
| 69-3645 | In distribution | |
| 69-3110 | In distribution | |
| 69-3126 | In distribution | |
| 69-3338 | In distribution | |
| 69-6050 | In distribution | |
| 69-2070 | In distribution | |
| 69-6100 | In distribution | |
| 69-2112 | In distribution | |
| 69-2008 | In distribution | |
| 69-3132 | In distribution | |
| 69-3324 | In distribution | |
| 69-2010 | In distribution | |
| 69-5440 | In distribution | |
| 69-6075 | In distribution | |
| 69-4160 | In distribution | |
| 69-3446 | In distribution | |
| 69-4105 | In distribution | |
| 69-2120 | In distribution | |
| 69-6040 | In distribution | |
| 69-3228 | In distribution | |
| 69-5420 | In distribution | |
| 69-4140 | In distribution | |
| 69-6055 | In distribution | |
| 69-3344 | In distribution | |
| 69-3438 | In distribution | |
| 69-4150 | In distribution | |
| 69-6070 | In distribution | |
| 69-3238 | In distribution | |
| 69-4130 | In distribution | |
| 69-3352 | In distribution | |
| 69-3348 | In distribution | |
| 69-2208 | In distribution | |
| 69-2020 | In distribution | |
| 69-2014 | In distribution | |
| 69-3011 | In distribution | |
| 69-0023 | In distribution | |
| 69-4035 | In distribution | |
| 69-3312 | In distribution | |
| 69-5445 | In distribution | |
| 69-2006 | In distribution | |
| 69-2030 | In distribution | |
| 69-4170 | In distribution | |
| 69-3030 | In distribution | |
| 69-3128 | In distribution | |
| 69-3452 | In distribution | |
| 69-3336 | In distribution | |
| 69-4080 | In distribution | |
| 69-6090 | In distribution | |
| 69-6085 | In distribution | |
| 69-3418 | In distribution | |
| 69-6080 | In distribution | |
| 69-6405 | In distribution | |
| 69-3135 | In distribution | |
| 69-3625 | In distribution | |
| 69-3310 | In distribution | |
| 69-3530 | In distribution | |
| 69-4040 | In distribution | |
| 69-0120 | In distribution | |
| 69-3414 | In distribution | |
| 69-3448 | In distribution | |
| 69-3416 | In distribution | |
| 69-3615 | In distribution | |
| 69-6030 | In distribution | |
| 69-3440 | In distribution | |
| 69-6310 | In distribution | |
| 69-4110 | In distribution | |
| 69-4085 | In distribution | |
| 69-3620 | In distribution | |
| 69-3320 | In distribution | |
| 69-3515 | In distribution | |
| 69-3234 | In distribution | |
| 69-2141 | In distribution | |
| 69-3410 | In distribution | |
| 69-6095 | In distribution | |
| 69-2212 | In distribution | |
| 69-5430 | In distribution | |
| 69-3010 | In distribution | |
| 69-4065 | In distribution | |
| 69-4070 | In distribution | |
| 69-0110 | In distribution | |
| 69-3326 | In distribution | |
| 69-3640 | In distribution | |
| 69-2012 | In distribution | |
| 69-6045 | In distribution | |
| 69-3130 | In distribution | |
| 69-3430 | In distribution | |
| 69-3535 | In distribution | |
| 69-3222 | In distribution | |
| 69-3650 | In distribution | |
| 69-4045 | In distribution | |
| 69-3124 | In distribution | |
| 69-3314 | In distribution | |
| 69-0022 | In distribution | |
| 69-3240 | In distribution | |
| 69-4095 | In distribution | |
| 69-3316 | In distribution | |
| 69-2140 | In distribution | |
| 69-3330 | In distribution | |
| 69-3224 | In distribution | |
| 69-3318 | In distribution | |
| 69-0224 | In distribution | |
| 69-0112 | In distribution | |
| 69-3412 | In distribution | |
| 69-2110 | In distribution | |
| 69-6060 | In distribution | |
| 69-6065 | In distribution | |
| 69-3444 | In distribution | |
| 69-3140 | In distribution | |
| 69-3525 | In distribution | |
| 69-3426 | In distribution | |
| 69-4050 | In distribution | |
| 69-0070 | In distribution | |
| 69-6115 | In distribution | |
| 69-4180 | In distribution | |
| 69-3226 | In distribution | |
| 69-3346 | In distribution | |
| 69-0233 | In distribution | |
| 69-2210 | In distribution | |
| 69-3230 | In distribution | |
| 69-4190 | In distribution | |
| 69-2206 | In distribution | |
| 69-3635 | In distribution | |
| 69-6105 | In distribution | |
| 69-0033 | In distribution | |
| 69-3340 | In distribution | |
| 69-4120 | In distribution | |
| 69-5425 | In distribution | |
| 69-0135 | In distribution | |
| 69-0200 | In distribution | |
| 69-5435 | In distribution | |
| 69-3428 | In distribution | |
| 69-3328 | In distribution | |
| 69-3520 | In distribution | |
| 69-3134 | In distribution | |
| 69-4090 | In distribution | |
| 69-4060 | In distribution | |
| 69-3232 | In distribution | |
| 69-6035 | In distribution | |
| 69-4030 | In distribution | |
| 69-4115 | In distribution | |
| 69-3442 | In distribution | |
| 69-3550 | In distribution | |
| 69-6425 | In distribution | |
| 69-3138 | In distribution | |
| 69-0223 | In distribution | |
| 69-3545 | In distribution | |
| 69-3420 | In distribution | |
| 69-3610 | In distribution | |
| 69-3136 | In distribution | |
| 69-4100 | In distribution | |
| 69-6110 | In distribution | |
| 69-3342 | In distribution | |
| 69-3540 | In distribution | |
| 69-2214 | In distribution | |
| 69-6120 | In distribution | |
| 69-3510 | In distribution | |
| 69-3112 | In distribution | |
| 69-3350 | In distribution | |
| 69-3630 | In distribution | |
| 69-2200 | In distribution | |
| 69-3436 | In distribution | |
| 69-2001 | In distribution | |
| 69-3424 | In distribution | |
| 69-3332 | In distribution | |
| 69-3236 | In distribution | |
| 69-5450 | In distribution | |
| 69-3122 | In distribution | |
| 69-2135 | In distribution | |
| 69-3322 | In distribution | |
| 69-3432 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bridalveil | Astura Medical | 1,718 |
| Proficient™ Posterior Cervical Spine System | Spine Wave, Inc. | 1,590 |
| Invictus | Alphatec Spine, Inc. | 1,538 |
| Paeon Posterior Cervical Fixation System | Aegis Spine | 1,408 |
| ReLine | Nuvasive, Inc. | 1,072 |
| PathLoc-C Posterior Cervical Fixation System | L&K Biomed Co., Ltd. | 706 |
| Cosy | Signus Medizintechnik Gmbh | 550 |
| Yukon OCT Spinal System | VB Spine LLC | 451 |
| Astra-OCT Spine System | Spinecraft LLC | 440 |
| Symphony | Medos International Sàrl | 389 |
| Medyssey Poseidon OCT Spinal Fixation System | Medyssey Co., Ltd. | 387 |
| Infinity™ Occipitocervical Upper Thoracic System | Medtronic Sofamor Danek, Inc. | 375 |
Showing 12 of 336. All products under Posterior Cervical Screw System
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2018-02-23 | Class II | Nonconforming Material/Component | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company’s manuf | 188 units | 2019-06-18 |
| 2018-02-23 | Class II | Nonconforming Material/Component | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company’s manuf | 397 units | 2019-06-18 |
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.