Saxxony™ Posterior Cervical Thoracic System
Transition Rod, CoCr, Ø3.5 to Ø5.5 x 400mm
4manufacturers in China registered for this device type
76catalogue numbers in this listing
1510(k) clearance
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 | Nexxt Spine LLC, United States |
|---|---|
| FDA product code | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K182508 |
| Record published | 2019-06-05 |
| Record revised | 2023-04-04 (version 4) |
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, serial number |
| Sizes | Length 8 to 400 mm; outer diameter 3.5 to 5.5 mm |
| Distribution end date | 2019-08-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C12-02-14 | In distribution | |
| C12-02-01 | In distribution | |
| 12-PS-4550 | Length 50 mm | In distribution |
| 12-HH-45 | In distribution | |
| 12-PS-4020 | Length 20 mm | In distribution |
| C12-02-07 | In distribution | |
| 12-PS-4018 | Outer Diameter 4.0 mm | In distribution |
| 12-PS-5040 | Length 40 mm | In distribution |
| 12-PR-3535 | Outer Diameter 3.5 mm | In distribution |
| 12-SS-4024 | Outer Diameter 4.0 mm | In distribution |
| 12-SS-3522 | Outer Diameter 3.5 mm | In distribution |
| 12-LC-05 | In distribution | |
| 12-PS-4520 | Length 20 mm | In distribution |
| 12-SS-4036 | Outer Diameter 4.0 mm | In distribution |
| 12-PS-3528 | Outer Diameter 3.5 mm | In distribution |
| 12-PR-3570 | Outer Diameter 3.5 mm | In distribution |
| 12-PS-4045 | Length 45 mm | In distribution |
| 12-SS-3518 | Outer Diameter 3.5 mm | In distribution |
| I12-535 | Outer Diameter 3.5 mm | In distribution |
| 12-PS-3524 | Outer Diameter 3.5 mm | In distribution |
| 12-AN-3540 | Outer Diameter 5.5 mm | In distribution |
| 12-PR-35120 | Outer Diameter 3.5 mm | In distribution |
| C12-02-05 | In distribution | |
| 12-WD-33 | In distribution | |
| 12-PS-4035 | Length 35 mm | In distribution |
| 12-PS-3512 | Outer Diameter 3.5 mm | In distribution |
| 12-PR-3590 | Outer Diameter 3.5 mm | In distribution |
| 12-RR-32 | In distribution | |
| 12-PS-4530 | Length 30 mm | In distribution |
| 12-PR-3525 | Outer Diameter 3.5 mm | In distribution |
| 12-HH-55 | In distribution | |
| 12-HK-MD | In distribution | |
| 12-SS-4032 | Outer Diameter 4.0 mm | In distribution |
| 12-EE-35 | In distribution | |
| 12-AN-3325 | Outer Diameter 3.5 mm | In distribution |
| C12-01-01 | In distribution | |
| C12-02-16 | In distribution | |
| 12-PS-4024 | Length 24 mm | In distribution |
| 12-SS-3534 | Outer Diameter 3.5 mm | In distribution |
| I12-182 | In distribution | |
| 12-SS-4040 | Outer Diameter 4.0 mm | In distribution |
| 12-PR-3550 | Outer Diameter 3.5 mm | In distribution |
| 12-SS-4028 | Outer Diameter 4.0 mm | In distribution |
| 12-PS-5025 | Length 25 mm | In distribution |
| 12-PS-3508 | Outer Diameter 3.5 mm | In distribution |
| 12-PR-35100 | Outer Diameter 3.5 mm | In distribution |
| 12-SS-3526 | Outer Diameter 3.5 mm | In distribution |
| I12-181 | In distribution | |
| 12-DM-35 | In distribution | |
| 12-HH-35 | In distribution | |
| I12-545 | Outer Diameter 4.5 mm | In distribution |
| 12-PS-4014 | Outer Diameter 4.0 mm | In distribution |
| 12-AN-3516 | Outer Diameter 5.5 mm | In distribution |
| 12-SR-35120 | Outer Diameter 3.5 mm | In distribution |
| 12-SS-3542 | Outer Diameter 3.5 mm | In distribution |
| 12-PS-4010 | Outer Diameter 4.0 mm | In distribution |
| I12-200 | In distribution | |
| 12-RR-44 | In distribution | |
| 12-TR-C400 | Length 400 mm | In distribution |
| 12-SS-3538 | Outer Diameter 3.5 mm | In distribution |
| 12-PS-3520 | Outer Diameter 3.5 mm | In distribution |
| 12-SR-3560 | Outer Diameter 3.5 mm | In distribution |
| 12-PS-3516 | Outer Diameter 3.5 mm | In distribution |
| 12-PS-4540 | Length 40 mm | In distribution |
| 12-SS-4020 | Outer Diameter 4.0 mm | In distribution |
| 12-PS-4028 | Length 28 mm | In distribution |
| 12-PR-3580 | Outer Diameter 3.5 mm | In distribution |
| 12-DW-33 | In distribution | |
| 12-SS-3530 | Outer Diameter 3.5 mm | In distribution |
| I12-183 | In distribution | |
| 12-AN-5312 | Outer Diameter 3.5 mm | In distribution |
| 12-PR-35110 | Outer Diameter 3.5 mm | In distribution |
| 12-AN-5340 | Outer Diameter 3.5 mm | In distribution |
| 12-SS-4044 | Outer Diameter 4.0 mm | In distribution |
| I12-812 | Length 12 mm | Withdrawn |
| I12-816 | Length 16 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182508 | 2018-11-13 |
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.