Premier
by Shandong Weigao Orthopaedic Device Company Limited. 2 variants
510(k) K160320
Premier is a Class II device made by Shandong Weigao Orthopaedic Device Company Limited., cleared under FDA 510(k) K160320 on 1 Apr 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160320 | Date1 Apr 2016 | StatusActive |
Official records
- FDA 510(k) database K160320
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNI
- FDA applicant
- Shandong Weigao Orthopaedic Device Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K160320
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Connection Rod 8005035 | 8005035 | 06912547138051 | — | On the market |
| Connection Rod 8005055 | 8005055 | 06912547138099 | — | On the market |
| Connection Rod 8005110 | 8005110 | 06912547138204 | — | On the market |
| Fixed-Angle Reduction Screw 8245040 | 8245040 | 06939488331624 | — | On the market |
| Fixed-Angle Reduction Screw 8245550 | 8245550 | 06939488331716 | — | On the market |
| Fixed-Angle Reduction Screw 8247040 | 8247040 | 06939488331945 | — | On the market |
| Fixed-Angle Reduction Screw 8247045 | 8247045 | 06939488331952 | — | On the market |
| Fixed-Angle Reduction Screw 8247565 | 8247565 | 06939488332089 | — | On the market |
| Fixed-Angle Reduction Screw 8248060 | 8248060 | 06912547300410 | — | No longer on the market |
| Fixed-Angle Reduction Screw 8248525 | 8248525 | 06912547300434 | — | No longer on the market |
| Fixed-Angle Screw 8234520 | 8234520 | 06912547086307 | — | On the market |
| Fixed-Angle Screw 8234535 | 8234535 | 06939488395497 | — | On the market |
| Fixed-Angle Screw 8236055 | 8236055 | 06939488395749 | — | On the market |
| Fixed-Angle Screw 8236545 | 8236545 | 06939488395817 | — | On the market |
| Fixed-Angle Screw 8237025 | 8237025 | 06939488395862 | — | On the market |
| Fixed-Angle Screw 8238565 | 8238565 | 06912547300335 | — | No longer on the market |
| Iliac Screws 803537565 | 803537565 | 06912547143697 | — | On the market |
| Iliac Screws 803539095 | 803539095 | 06912547300564 | — | No longer on the market |
| Iliac Screws 803539575 | 803539575 | 06912547300588 | — | No longer on the market |
| Iliac Screws 803539585 | 803539585 | 06912547300601 | — | No longer on the market |
| Iliac Screws 803539600 | 803539600 | 06912547300632 | — | No longer on the market |
| Multi-Axial Reduction Screw 8224545 | 8224545 | 06939488330931 | — | On the market |
| Multi-Axial Reduction Screw 8225055 | 8225055 | 06939488331020 | — | On the market |
| Multi-Axial Reduction Screw 8225540 | 8225540 | 06939488331068 | — | On the market |
| Multi-Axial Reduction Screw 8226030 | 8226030 | 06939488331112 | — | On the market |
| Multi-Axial Reduction Screw 8226040 | 8226040 | 06939488331136 | — | On the market |
| Multi-Axial Reduction Screw 8226065 | 8226065 | 06939488331181 | — | On the market |
| Multi-Axial Reduction Screw 8226555 | 8226555 | 06939488331259 | — | On the market |
| Multi-Axial Reduction Screw 8227040 | 8227040 | 06939488331310 | — | On the market |
| Multi-Axial Reduction Screw 8227055 | 8227055 | 06939488331341 | — | On the market |
| Multi-Axial Reduction Screw 8227525 | 8227525 | 06939488331372 | — | On the market |
| Multi-Axial Reduction Screw 8227565 | 8227565 | 06939488331457 | — | On the market |
| Multi-Axial Screw 8214520 | 8214520 | 06912547086260 | — | On the market |
| Multi-Axial Screw 8214540 | 8214540 | 06939488394872 | — | On the market |
| Multi-Axial Screw 8215030 | 8215030 | 06939488394926 | — | On the market |
| Multi-Axial Screw 8215035 | 8215035 | 06939488394933 | — | On the market |
| Multi-Axial Screw 8215050 | 8215050 | 06939488394964 | — | On the market |
| Multi-Axial Screw 8216040 | 8216040 | 06939488395084 | — | On the market |
| Multi-Axial Screw 8216540 | 8216540 | 06939488395176 | — | On the market |
| Multi-Axial Screw 8217040 | 8217040 | 06939488395268 | — | On the market |
| Multi-Axial Screw 8217060 | 8217060 | 06939488395305 | — | On the market |
| Multi-Axial Screw 8217545 | 8217545 | 06939488395367 | — | On the market |
| Planar Screw 8264525 | 8264525 | 06939488332195 | — | On the market |
| Planar Screw 8264526 | 8264526 | 06939488332201 | — | On the market |
| Planar Screw 8265025 | 8265025 | 06939488332300 | — | On the market |
| Planar Screw 8265045 | 8265045 | 06939488332348 | — | On the market |
| Planar Screw 8266540 | 8266540 | 06939488332560 | — | On the market |
| Planar Screw 8266545 | 8266545 | 06939488332577 | — | On the market |
| Planar Screw 8267025 | 8267025 | 06939488332621 | — | On the market |
| Planar Screw 8267035 | 8267035 | 06939488332645 | — | On the market |
Similar devices
Other devices filed under FDA product code MNI (Orthosis, Spinal Pedicle Fixation).
- Erisma®-LP 13733002 by Clariance, Inc.
- PASS SPINAL SYSTEM by Encore Orthopedics, Inc.
- CAPSURE PS (R) SPINE SYSTEM by Spine Wave, Inc.
- CD HORIZON SPINAL SYSTEM by Sofamor Danek USA, Inc.
- ROMEO Posterior Osteosynthesis System ELL-RD 40 80-N by Spineart
- PLUS PIVOT LINK UNIVERSAL SYSTEM by Spine Vision, Inc.
- Erisma®-LP 18174535 by Clariance, Inc.
- SYNERGY 4.0 MM, 4.5 MM VLS SCREWS by Interpore Cross Intl.
- ART POSTERIOR SPINAL SYSTEM by Advanced Medical Technologies AG
- CD HORIZON® Spinal System 55840005540 by MEDTRONIC SOFAMOR DANEK, INC.
Other devices from Shandong Weigao Orthopaedic Device Company Limited.
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