Astra-OCT Spine System
The ASTRA-OCT connector belongs to a spinal fixation system for the craniocervical junction, cervical spine and upper thoracic spine. The system combines screws, occipital plates, hooks,…
The ASTRA-OCT connector belongs to a spinal fixation system for the craniocervical junction, cervical spine and upper thoracic spine. The system combines screws, occipital plates, hooks, rods and several connector types to immobilize and stabilize segments as an adjunct to fusion.
Corresponding connectors allow ASTRA-OCT rods to join other occipital-cervical-thoracic or thoracolumbar rod systems with diameters from 3.5 to 6.35 mm, including ASTRA and APEX systems. The broader implant range uses titanium and cobalt-chromium alloys; material is selected by component.
Listed Item
ASTRA-OCT Side-by-Side Connector, Open Side-Loading, fitting Dia. 5.5/6.0/6.35mm
Construct Applications
System indications include traumatic fractures or dislocations, instability, deformity, failed fusion, tumors and specified degenerative disease. The anatomical range includes C1 to C7 and T1 to T3. A separate limited-duration indication covers cervical tumors when life expectancy is too short for fusion to develop.
4manufacturers in China registered for this device type
440catalogue 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 | Spinecraft 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, Manufacturer |
| 510(k) | K181350 |
| Record published | 2018-10-03 |
| Record revised | 2024-09-11 (version 6) |
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 |
| Distribution end date | 2024-09-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A3P-3546 | In distribution | |
| A3R-40-050K | In distribution | |
| A3P-4028 | In distribution | |
| A3R-40-080 | In distribution | |
| A3P-4518R | In distribution | |
| A3P-4028R-S | In distribution | |
| A3P-4012 | In distribution | |
| A3OR-40-6020 | In distribution | |
| A3P-5520 | In distribution | |
| A3T-C45-28 | In distribution | |
| A3P-3510R | In distribution | |
| A3P-4550R | In distribution | |
| A3P-3524R | In distribution | |
| A3H-AR65 | In distribution | |
| A3R-40-100 | In distribution | |
| A3OR-35-6020 | In distribution | |
| A3P-4538R | In distribution | |
| A3P-4030R | In distribution | |
| A3P-4032R | In distribution | |
| A3P-4522 | In distribution | |
| A3OS-5012 | In distribution | |
| A3P-5530 | In distribution | |
| A3P-4044R-S | In distribution | |
| A3P-5540R | In distribution | |
| A3X-S33 | In distribution | |
| A3OR-35-9020K | In distribution | |
| A3OS-5010 | In distribution | |
| A3P-4046R | In distribution | |
| A3P-4020R-S | In distribution | |
| A3R-35-450K | In distribution | |
| A3P-4038R-S | In distribution | |
| A3P-4512 | In distribution | |
| A3P-3510 | In distribution | |
| A3R-T45-500K | In distribution | |
| A3P-3512R | In distribution | |
| A3P-3526 | In distribution | |
| A3R-40-070 | In distribution | |
| A3P-5025R | In distribution | |
| A3P-4026 | In distribution | |
| A3R-40-025K | In distribution | |
| A3P-5015 | In distribution | |
| A3R-35-025K | In distribution | |
| A3P-4040R-S | In distribution | |
| A3OR-35-9032 | In distribution | |
| A3ZR-409-325 | In distribution | |
| A3OR-40-9030K | In distribution | |
| A3S-T15 | In distribution | |
| A3L-C20 | In distribution | |
| A3P-3516R | In distribution | |
| A3ZR-357-325K | In distribution | |
| A3R-35-300K | In distribution | |
| A3H-LO65 | In distribution | |
| A3P-4520R | In distribution | |
| A3R-40-030 | In distribution | |
| A3OR-40-6030K | In distribution | |
| A3P-4038R | In distribution | |
| A3R-T35-325K | In distribution | |
| A3R-35-300 | In distribution | |
| A3P-4530 | In distribution | |
| A3P-5525 | In distribution | |
| A3ZR-357-100 | In distribution | |
| A3P-5025 | In distribution | |
| A3L-C25 | In distribution | |
| A3P-3520R | In distribution | |
| A3P-4042-S | In distribution | |
| A3P-4514 | In distribution | |
| A3OR-40-6030 | In distribution | |
| A3ZR-359-200 | In distribution | |
| A3P-3536R-S | In distribution | |
| A3P-4042 | In distribution | |
| A3D-OS35 | In distribution | |
| A3R-35-045 | In distribution | |
| A3P-4050 | In distribution | |
| A3R-40-045K | In distribution | |
| A3P-4510R | In distribution | |
| A3P-3532-S | In distribution | |
| A3P-4032R-S | In distribution | |
| A3P-5535R | In distribution | |
| A3P-3524 | In distribution | |
| A3R-T44-325 | In distribution | |
| A3R-40-020K | In distribution | |
| A3OR-35-9032K | In distribution | |
| A3OS-4514 | In distribution | |
| A3P-5545 | In distribution | |
| A3P-4550 | In distribution | |
| A3P-4016R | In distribution | |
| A3P-4022R | In distribution | |
| A3P-4540R | In distribution | |
| A3P-4538 | In distribution | |
| A3P-3526R | In distribution | |
| A3L-C15 | In distribution | |
| A3P-5515R | In distribution | |
| A3P-4038 | In distribution | |
| A3P-3528R | In distribution | |
| A3H-AL45 | In distribution | |
| A3P-5535 | In distribution | |
| A3P-4044R | In distribution | |
| A3D-OS45 | In distribution | |
| A3P-4548R | In distribution | |
| A3P-5050 | In distribution | |
| A3P-3542R-S | In distribution | |
| A3ZR-407-100K | In distribution | |
| A3H-RO65 | In distribution | |
| A3ZR-407-200 | In distribution | |
| A3P-5035 | In distribution | |
| A3OR-40-7530 | In distribution | |
| A3OR-40-9032K | In distribution | |
| A3P-4546 | In distribution | |
| A3P-5050R | In distribution | |
| A3OR-35-7530K | In distribution | |
| A3X-S45 | In distribution | |
| A3P-5540 | In distribution | |
| A3P-4024 | In distribution | |
| A3OR-35-6032K | In distribution | |
| A3P-3524R-S | In distribution | |
| A3P-4532R | In distribution | |
| A3OS-4510 | In distribution | |
| A3P-4018 | In distribution | |
| A3OS-5018 | In distribution | |
| A3OS-5016 | In distribution | |
| A3P-4036 | In distribution | |
| A3P-4032 | In distribution | |
| A3H-AR55 | In distribution | |
| A3P-4536R | In distribution | |
| A3OR-35-7532 | In distribution | |
| A3R-40-080K | In distribution | |
| A3R-40-060 | In distribution | |
| A3R-35-020K | In distribution | |
| A3T-C55-28 | In distribution | |
| A3OR-40-7532K | In distribution | |
| A3P-4534R | In distribution | |
| A3H-L65 | In distribution | |
| A3P-3530R | In distribution | |
| A3P-4022 | In distribution | |
| A3P-4540 | In distribution | |
| A3P-4026R | In distribution | |
| A3P-4014 | In distribution | |
| A3OR-35-6032 | In distribution | |
| A3P-5020R | In distribution | |
| A3P-4050R | In distribution | |
| A3P-4030-S | In distribution | |
| A3P-4038-S | In distribution | |
| A3P-4518 | In distribution | |
| A3P-3542 | In distribution | |
| A3L-OSA15 | In distribution | |
| A3P-4028-S | In distribution | |
| A3P-3540-S | In distribution | |
| A3P-3540 | In distribution | |
| A3P-4020-S | In distribution | |
| A3R-T35-500 | In distribution | |
| A3P-4026R-S | In distribution | |
| A3P-4030R-S | In distribution | |
| A3D-C55 | In distribution | |
| A3R-35-050K | In distribution | |
| A3L-OSA25 | In distribution | |
| A3OR-40-6032K | In distribution | |
| A3P-4048-S | In distribution | |
| A3R-40-050 | In distribution | |
| A3P-4044 | In distribution | |
| A3OR-35-7530 | In distribution | |
| A3P-4026-S | In distribution | |
| A3R-40-300 | In distribution | |
| A3P-3522-S | In distribution | |
| A3P-4024-S | In distribution | |
| A3P-3548-S | In distribution | |
| A3P-4048R-S | In distribution | |
| A3P-4046R-S | In distribution | |
| A3ZR-409-100 | In distribution | |
| A3L-OS15 | In distribution | |
| A3P-5040R | In distribution | |
| A3R-35-025 | In distribution | |
| A3OR-40-9020K | In distribution | |
| A3P-3518R-S | In distribution | |
| A3P-4050R-S | In distribution | |
| A3R-40-045 | In distribution | |
| A3P-4510 | In distribution | |
| A3ZR-407-100 | In distribution | |
| A3OS-5008 | In distribution | |
| A3R-35-020 | In distribution | |
| A3OR-35-6030 | In distribution | |
| A3P-3522R | In distribution | |
| A3P-4544 | In distribution | |
| A3S-XT15 | In distribution | |
| A3D-OS55 | In distribution | |
| A3X-R3135 | In distribution | |
| A3P-4034 | In distribution | |
| A3P-4532 | In distribution | |
| A3P-5015R | In distribution | |
| A3P-4016 | In distribution | |
| A3P-4028R | In distribution | |
| A3P-3528 | In distribution | |
| A3R-40-450 | In distribution | |
| A3T-C35-28 | In distribution | |
| A3L-OSA20 | In distribution | |
| A3OR-40-9020 | In distribution | |
| A3OR-35-7520K | In distribution | |
| A3P-4020R | In distribution | |
| A3P-3530-S | In distribution | |
| A3R-40-030K | In distribution | |
| A3P-4524 | In distribution | |
| A3R-35-030 | In distribution | |
| A3P-5040 | In distribution | |
| A3P-5550R | In distribution | |
| A3P-4046-S | In distribution | |
| A3ZR-409-200 | In distribution | |
| A3R-35-200K | In distribution | |
| A3P-4516R | In distribution | |
| A3ZR-359-100K | In distribution | |
| A3P-3540R | In distribution | |
| A3OP-A32 | In distribution | |
| A3P-3518 | In distribution | |
| A3P-3538R | In distribution | |
| A3P-4542R | In distribution | |
| A3P-3524-S | In distribution | |
| A3P-3534R | In distribution | |
| A3P-4546R | In distribution | |
| A3D-C45 | In distribution | |
| A3P-4528R | In distribution | |
| A3S-T15F | In distribution | |
| A3OS-5012 | Withdrawn | |
| A3R-T44-325 | Withdrawn | |
| A3P-5050R | Withdrawn | |
| A3P-3512 | Withdrawn | |
| A3P-3528-S | Withdrawn | |
| A3P-4050-S | Withdrawn | |
| A3ZR-409-200K | Withdrawn | |
| A3OS-5018 | Withdrawn | |
| A3OR-35-7532 | Withdrawn | |
| A3P-5035 | Withdrawn | |
| A3P-3528R-S | Withdrawn | |
| A3P-3526R-S | Withdrawn | |
| A3P-4024R-S | Withdrawn | |
| A3H-LO45 | Withdrawn | |
| A3P-5525 | Withdrawn | |
| A3S-T15 | Withdrawn | |
| A3OR-35-9020K | Withdrawn | |
| A3R-35-070K | Withdrawn | |
| A3P-5015R | Withdrawn | |
| A3P-4032 | Withdrawn | |
| A3R-35-040 | Withdrawn | |
| A3P-3544 | Withdrawn | |
| A3P-3550R | Withdrawn | |
| A3P-4032-S | Withdrawn | |
| A3P-5515 | Withdrawn | |
| A3R-40-060 | Withdrawn | |
| A3T-C55-15 | Withdrawn | |
| A3P-3538R-S | Withdrawn | |
| A3P-5030R | Withdrawn | |
| A3P-4022 | Withdrawn | |
| A3P-4050R-S | Withdrawn |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Perla ® | Spineart SA | 349 |
Showing 12 of 336. All products under Posterior Cervical Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181350 | 2018-07-06 |
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.