Ennovate C
ENNOVATE C Dilator, large, non-sterile, reusable, to be used with: SZ145R
4manufacturers in China registered for this device type
234catalogue numbers in this listing
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 | Aesculap AG, Germany |
|---|---|
| FDA product code | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-03-05 |
| Record revised | 2025-11-13 (version 5) |
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 |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2024-12-12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SQ403TS | Length : 32.000 MM | Withdrawn | |
| SQ416TS | Length : 38.000 MM | Withdrawn | |
| SQ624TS | Diameter (mm) : 3.600 MM | Withdrawn | |
| SZ141R | Withdrawn | ||
| SQ060TS | Length : 26.000 – 28.000 MM | Withdrawn | |
| SQ902TS | Figure/Size : small | Withdrawn | |
| SQ029TS | Length : 24.000 MM | Withdrawn | |
| SZ133R | Withdrawn | ||
| SZ052R | Withdrawn | ||
| SQ122TS | Length : 22.000 MM | Withdrawn | |
| SQ059TS | Length : 24.000 MM | Withdrawn | |
| SQ916TS | Diameter (mm) : 4.500 MM | Withdrawn | |
| SQ348TS | Length : 48.000 MM | Withdrawn | |
| SZ069R | Withdrawn | ||
| SQ690TS | Diameter (mm) : 4.500 MM | Withdrawn | |
| SZ003R | Withdrawn | ||
| SQ682TS | Length : 32.000 MM | Withdrawn | |
| SQ914TS | Length : 14.000 MM | Withdrawn | |
| SZ102R | Withdrawn | ||
| SQ008KS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SZ114R | Withdrawn | ||
| SZ151R | Withdrawn | ||
| SQ350TS | Length : 50.000 MM | Withdrawn | |
| SQ652TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ234TS | Length : 34.000 MM | Withdrawn | |
| SQ022TS | Withdrawn | ||
| SQ603TS | Length : 30.000 MM | Withdrawn | |
| SQ636TS | Length : 26.000 MM | Withdrawn | |
| SQ342TS | Length : 42.000 MM | Withdrawn | |
| SQ620TS | Length : 10.000 MM | Withdrawn | |
| SQ214TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SZ015R | Withdrawn | ||
| SZ019R | Withdrawn | ||
| SZ123SU | Withdrawn | ||
| SZ143R | Withdrawn | ||
| SZ139R | Withdrawn | ||
| SQ664TS | Length : 24.000 MM | Withdrawn | |
| SZ104R | Withdrawn | ||
| SQ930TS | Length : 10.000 MM | Withdrawn | |
| SQ444TS | Length : 24.000 MM | Withdrawn | |
| SQ903TS | Figure/Size : large | Withdrawn | |
| SQ934TS | Diameter (mm) : 5.500 MM | Withdrawn | |
| SQ110TS | Length : 10.000 MM | Withdrawn | |
| SQ130TS | Diameter (mm) : 3.600 MM | Withdrawn | |
| SQ004TS | Length : 150.000 MM | Withdrawn | |
| SQ452TS | Length : 32.000 MM | Withdrawn | |
| SQ052TS | Withdrawn | ||
| SQ406TS | Length : 38.000 MM | Withdrawn | |
| SQ404TS | Diameter (mm) : 3.600 MM | Withdrawn | |
| SQ003TS | Diameter (mm) : 3.500 MM | Withdrawn | |
| SQ168TS | Length : 18.000 MM | Withdrawn | |
| SQ126TS | Diameter (mm) : 3.600 MM | Withdrawn | |
| SQ936TS | Diameter (mm) : 5.500 MM | Withdrawn | |
| SZ089R | Withdrawn | ||
| SQ366TS | Length : 36.000 MM | Withdrawn | |
| SZ061R | Withdrawn | ||
| SQ236TS | Length : 36.000 MM | Withdrawn | |
| SQ908TS | Length : 8.000 MM | Withdrawn | |
| SZ149R | Withdrawn | ||
| SQ606TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ456TS | Length : 36.000 MM | Withdrawn | |
| SZ013R | Withdrawn | ||
| SQ604TS | Length : 40.000 MM | Withdrawn | |
| SZ001R | Withdrawn | ||
| SQ660TS | Length : 20.000 MM | Withdrawn | |
| SQ037TS | Length : 42.000 – 58.000 MM | Withdrawn | |
| SQ668TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ007KS | Length : 60.000 MM | Withdrawn | |
| SZ107R | Withdrawn | ||
| SZ103R | Withdrawn | ||
| SQ900TS | Figure/Size : small | Withdrawn | |
| SQ626TS | Length : 16.000 MM | Withdrawn | |
| SQ226TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ134TS | Length : 34.000 MM | Withdrawn | |
| SQ901TS | Figure/Size : large | Withdrawn | |
| SZ014R | Withdrawn | ||
| SQ400TS | Length : 26.000 MM | Withdrawn | |
| SQ634TS | Diameter (mm) : 3.600 MM | Withdrawn | |
| SQ025TS | Withdrawn | ||
| SQ932TS | Diameter (mm) : 5.500 MM | Withdrawn | |
| SZ147R | Withdrawn | ||
| SQ607TS | Length : 70.000 MM | Withdrawn | |
| SQ230TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ266TS | Length : 16.000 MM | Withdrawn | |
| SQ658TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ264TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ112TS | Diameter (mm) : 3.600 MM | Withdrawn | |
| SQ640TS | Diameter (mm) : 3.600 MM | Withdrawn | |
| SZ058R | Withdrawn | ||
| SQ608TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ413TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ034TS | Length : 24.000 – 28.000 MM | Withdrawn | |
| SQ666TS | Length : 26.000 MM | Withdrawn | |
| SQ006TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ005TS | Length : 60.000 MM | Withdrawn | |
| SZ140R | Withdrawn | ||
| SQ906TS | Diameter (mm) : 4.500 MM | Withdrawn | |
| SQ686TS | Length : 36.000 MM | Withdrawn | |
| SZ068R | Withdrawn | ||
| SQ622TS | Diameter (mm) : 3.600 MM | Withdrawn | |
| SQ051TS | Withdrawn | ||
| SZ121SU | Withdrawn | ||
| SQ678TS | Length : 28.000 MM | Withdrawn | |
| SZ109R | Withdrawn | ||
| SQ030TS | Length : 26.000 – 28.000 MM | Withdrawn | |
| SZ116R | Withdrawn | ||
| SQ417TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ268TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SZ108R | Withdrawn | ||
| SZ080R | Withdrawn | ||
| SQ910TS | Diameter (mm) : 4.500 MM | Withdrawn | |
| SQ411TS | Length : 28.000 MM | Withdrawn | |
| SQ136TS | Diameter (mm) : 3.600 MM | Withdrawn | |
| SZ027R | Length : 250.000 MM | Withdrawn | |
| SZ112R | Withdrawn | ||
| SZ134R | Withdrawn | ||
| SQ650TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SZ004R | Withdrawn | ||
| SQ376TS | Length : 46.000 MM | Withdrawn | |
| SZ055R | Withdrawn | ||
| SQ061TS | Length : 28.000 – 33.000 MM | Withdrawn | |
| SQ114TS | Length : 14.000 MM | Withdrawn | |
| SQ415TS | Length : 36.000 MM | Withdrawn | |
| SQ654TS | Length : 14.000 MM | Withdrawn | |
| SQ412TS | Length : 30.000 MM | Withdrawn | |
| SQ380TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ336TS | Length : 36.000 MM | Withdrawn | |
| SQ928TS | Length : 8.000 MM | Withdrawn | |
| SZ048R | Withdrawn | ||
| SQ232TS | Length : 32.000 MM | Withdrawn | |
| SZ120SU | Withdrawn | ||
| SZ006R | Withdrawn | ||
| SZ005R | Withdrawn | ||
| SQ116TS | Diameter (mm) : 3.600 MM | Withdrawn | |
| SQ912TS | Length : 12.000 MM | Withdrawn | |
| SQ662TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ128TS | Length : 28.000 MM | Withdrawn | |
| SQ216TS | Length : 16.000 MM | Withdrawn | |
| SQ011TS | Length : 7.000 MM | Withdrawn | |
| SQ410TS | Length : 26.000 MM | Withdrawn | |
| SQ218TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SZ111R | Withdrawn | ||
| SZ105R | Withdrawn | ||
| SQ166TS | Length : 16.000 MM | Withdrawn | |
| SQ020TS | Withdrawn | ||
| SQ632TS | Diameter (mm) : 3.600 MM | Withdrawn | |
| SQ612TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ032TS | Length : 33.000 – 42.000 MM | Withdrawn | |
| SQ132TS | Length : 32.000 MM | Withdrawn | |
| SQ063TS | Length : 42.000 – 58.000 MM | Withdrawn | |
| SQ609TS | Length : 90.000 MM | Withdrawn | |
| SQ460TS | Length : 40.000 MM | Withdrawn | |
| SQ124TS | Diameter (mm) : 3.600 MM | Withdrawn | |
| SZ016R | Withdrawn | ||
| SZ002R | Withdrawn | ||
| SZ051R | Withdrawn | ||
| SQ228TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ021TS | Withdrawn | ||
| SZ113R | Withdrawn | ||
| SZ060R | Withdrawn | ||
| SZ059R | Withdrawn | ||
| SQ628TS | Length : 18.000 MM | Withdrawn | |
| SZ148R | Withdrawn | ||
| SQ414TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SZ119SU | Withdrawn | ||
| SZ011R | 2 | Withdrawn | |
| SZ064R | Withdrawn | ||
| SZ063R | Withdrawn | ||
| SQ024TS | Withdrawn | ||
| SQ638TS | Length : 28.000 MM | Withdrawn | |
| SQ378TS | Length : 48.000 MM | Withdrawn | |
| SQ035TS | Length : 28.000 – 33.000 MM | Withdrawn | |
| SZ066R | Withdrawn | ||
| SQ118TS | Length : 18.000 MM | Withdrawn | |
| SZ050R | Withdrawn | ||
| SZ106R | Withdrawn | ||
| SZ082R | Withdrawn | ||
| SQ212TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ220TS | Length : 20.000 MM | Withdrawn | |
| SQ260TS | Length : 10.000 MM | Withdrawn | |
| SQ262TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ036TS | Length : 33.000 – 42.000 MM | Withdrawn | |
| SQ009TS | Length : 400.000 MM | Withdrawn | |
| SZ101R | Withdrawn | ||
| SQ368TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ023TS | Withdrawn | ||
| SQ401TS | Diameter (mm) : 3.600 MM | Withdrawn | |
| SQ033TS | Length : 42.000 – 58.000 MM | Withdrawn | |
| SQ210TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SZ053R | Withdrawn | ||
| SQ405TS | Length : 36.000 MM | Withdrawn | |
| SQ674TS | Length : 24.000 MM | Withdrawn | |
| SZ137R | 2 | Withdrawn | |
| SZ078R | Withdrawn | ||
| SQ338TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ001TS | Withdrawn | ||
| SQ370TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ670TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ012TS | Length : 7.000 MM | Withdrawn | |
| SQ010TS | Withdrawn | ||
| SQ630TS | Length : 20.000 MM | Withdrawn | |
| SQ611TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ062TS | Length : 33.000 – 42.000 MM | Withdrawn | |
| SQ017TS | Withdrawn | ||
| SZ054R | Withdrawn | ||
| SQ926TS | Diameter (mm) : 5.500 MM | Withdrawn | |
| SZ110R | Withdrawn | ||
| SQ656TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ605TS | Length : 50.000 MM | Withdrawn | |
| SQ374TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SZ018R | Withdrawn | ||
| SZ142R | Withdrawn | ||
| SZ017R | Withdrawn | ||
| SQ942TS | Length : 240.000 MM | Withdrawn | |
| SZ039R | Withdrawn | ||
| SQ402TS | Length : 30.000 MM | Withdrawn | |
| SQ344TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ050TS | Withdrawn | ||
| SQ002TS | 10 | Withdrawn | |
| SQ031TS | Length : 28.000 – 33.000 MM | Withdrawn | |
| SQ346TS | Length : 46.000 MM | Withdrawn | |
| SZ115R | Withdrawn | ||
| SQ053TS | Withdrawn | ||
| SQ448TS | Diameter (mm) : 4.500 MM | Withdrawn | |
| SQ610TS | Diameter (mm) : 4.000 MM | Withdrawn | |
| SQ372TS | Length : 42.000 MM | Withdrawn | |
| SQ120TS | Diameter (mm) : 3.600 MM | Withdrawn | |
| SQ340TS | Length : 40.000 MM | Withdrawn | |
| SQ222TS | Length : 22.000 MM | Withdrawn | |
| SQ940TS | Length : 240.000 MM | Withdrawn | |
| SZ132R | Withdrawn | ||
| SQ407TS | Length : 40.000 MM | Withdrawn | |
| SZ150R | Withdrawn | ||
| SQ224TS | Diameter (mm) : 4.000 MM | Withdrawn |
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
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.