Oasys
PRE-Contoured Occiput Plate Right
4manufacturers in China registered for this device type
86catalogue numbers in this listing
2510(k) clearances naming this product 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-14 |
| Record revised | 2024-09-11 (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, manufacturing date |
| Sizes | Length 3.5 to 860 mm; angle 100 to 130 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48555420 | Diameter: 4.0 Millimeter | In distribution |
| 48554450 | Diameter: 4.0 Millimeter | In distribution |
| 48555432 | Length 32.0 mm | In distribution |
| 48553604 | Length 600.0 mm | In distribution |
| 48553810 | Diameter: 3.5 Millimeter | In distribution |
| 48554410 | Diameter: 4.0 Millimeter | In distribution |
| 48552334 | Length 34.0 mm | In distribution |
| 48551045 | In distribution | |
| 48551084 | Length 3.5 mm | In distribution |
| 48552316 | Diameter: 3.5 Millimeter | In distribution |
| 48551043R | Angle 100.0 ° | In distribution |
| 48555452 | Length 52.0 mm | In distribution |
| 48554514 | Length 14.0 mm | In distribution |
| 48552418 | Length 18.0 mm | In distribution |
| 48554314 | Length 14.0 mm | In distribution |
| 48552440 | Diameter: 4.0 Millimeter | In distribution |
| 48558532 | Length 32.0 mm | In distribution |
| 48551073 | Length 24.0 mm | In distribution |
| 48553802 | Diameter: 3.5 Millimeter | In distribution |
| 48552436 | Length 36.0 mm | In distribution |
| 48553824 | Diameter: 3.5 Millimeter | In distribution |
| 48552060 | Length 60.0 mm | In distribution |
| 48554418 | Length 18.0 mm | In distribution |
| 48552330 | Diameter: 3.5 Millimeter | In distribution |
| 48552428 | Diameter: 4.0 Millimeter | In distribution |
| 48551049 | Length 3.5 mm | In distribution |
| 48553822 | Length 860.0 mm | In distribution |
| 48555424 | Diameter: 4.0 Millimeter | In distribution |
| 48552350 | Length 50.0 mm | In distribution |
| 48552320 | Length 20.0 mm | In distribution |
| 48552080 | Length 80.0 mm | In distribution |
| 48554508 | Diameter: 4.5 Millimeter | In distribution |
| 48557316 | Length 16.0 mm | In distribution |
| 48551240 | Diameter: 3.5 Millimeter | In distribution |
| 48552030 | Diameter: 3.5 Millimeter | In distribution |
| 48553808 | Diameter: 3.5 Millimeter | In distribution |
| 48554324 | Length 24.0 mm | In distribution |
| 48552120 | Length 120.0 mm | In distribution |
| 48552434 | Length 34.0 mm | In distribution |
| 48552426 | Diameter: 4.0 Millimeter | In distribution |
| 48552310 | Length 10.0 mm | In distribution |
| 48554434 | Diameter: 4.0 Millimeter | In distribution |
| 48558520 | Diameter: 4.5 Millimeter | In distribution |
| 48552340 | Length 40.0 mm | In distribution |
| 48558412 | Length 12.0 mm | In distribution |
| 48551065 | In distribution | |
| 48557314 | Length 14.0 mm | In distribution |
| 48552416 | Diameter: 4.0 Millimeter | In distribution |
| 48551085 | Length 3.5 mm | In distribution |
| 48557310 | Length 10.0 mm | In distribution |
| 48552344 | Length 44.0 mm | In distribution |
| 48554454 | Diameter: 4.0 Millimeter | In distribution |
| 48557410 | Diameter: 4.0 Millimeter | In distribution |
| 48552422 | Diameter: 4.0 Millimeter | In distribution |
| 48554308 | Length 8.0 mm | In distribution |
| 48552438 | Length 38.0 mm | In distribution |
| 48551053 | Length 6.5 mm | In distribution |
| 48554408 | Diameter: 4.0 Millimeter | In distribution |
| 48551041L | Angle 130.0 ° | In distribution |
| 48558318 | Length 18.0 mm | In distribution |
| 48558316 | Length 16.0 mm | In distribution |
| 48554506 | Length 6.0 mm | In distribution |
| 48556334 | Length 34.0 mm | In distribution |
| 48555440 | Length 40.0 mm | In distribution |
| 48557412 | Diameter: 4.0 Millimeter | In distribution |
| 48551090 | In distribution | |
| 48558540 | Length 40.0 mm | In distribution |
| 48554316 | Diameter: 3.5 Millimeter | In distribution |
| 48555444 | Length 44.0 mm | In distribution |
| 48552432 | Length 32.0 mm | In distribution |
| 48554422 | Diameter: 4.0 Millimeter | In distribution |
| 48554310 | Diameter: 3.5 Millimeter | In distribution |
| 48551044 | In distribution | |
| 48554516 | Diameter: 4.5 Millimeter | In distribution |
| 48555422 | Length 22.0 mm | In distribution |
| 48552412 | Diameter: 4.0 Millimeter | In distribution |
| 48556340 | Length 40.0 mm | In distribution |
| 48558552 | Diameter: 4.5 Millimeter | In distribution |
| 48553606 | Diameter: 5.5 Millimeter | In distribution |
| 48557422 | Length 22.0 mm | In distribution |
| 48551000 | In distribution | |
| 48555328 | Diameter: 3.5 Millimeter | In distribution |
| 48551074 | Length 32.0 mm | In distribution |
| 48552354 | Diameter: 3.5 Millimeter | In distribution |
| 48557424 | Diameter: 4.0 Millimeter | In distribution |
| 48551042 | Angle 100.0 ° | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151755 | 2015-07-09 |
| K150539 | 2015-05-12 |
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.