Premier
by Shandong Weigao Orthopaedic Device Company Limited. 2 variants
510(k) K170861
Premier is a Class II device made by Shandong Weigao Orthopaedic Device Company Limited., cleared under FDA 510(k) K170861 on 4 Aug 2017, 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 | NumberK170861 | Date4 Aug 2017 | StatusActive |
Official records
- FDA 510(k) database K170861
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NKB
- 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 K170861
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 | |||
|---|---|---|---|---|
| Closed Lateral Connector 803845525 | 803845525 | 06912547395010 | On the market | |
| Closed Lateral Connector 803845560 | 803845560 | 06912547395058 | On the market | |
| Curved Connection Rod 803805030 | 803805030 | 06912547394464 | On the market | |
| Curved Connection Rod 803805075 | 803805075 | 06912547394556 | On the market | |
| Curved Connection Rod 803805100 | 803805100 | 06912547394600 | On the market | |
| Curved Connection Rod 803805105 | 803805105 | 06912547394617 | On the market | |
| Fixed-Angle Reduction Screw 8248540 | 8248540 | 06912547393061 | On the market | |
| Fixed-Angle Reduction Screw 8248555 | 8248555 | 06912547393092 | On the market | |
| Fixed-Angle Screw 8238040 | 8238040 | 06912547392798 | On the market | |
| Fixed-Angle Screw 8238045 | 8238045 | 06912547392804 | On the market | |
| Fixed-Angle Screw 8238050 | 8238050 | 06912547392811 | On the market | |
| Fixed-Angle Screw 8238065 | 8238065 | 06912547392842 | On the market | |
| Fixed-Angle Screw 8238550 | 8238550 | 06912547392903 | On the market | |
| Iliac Screws 803530565 | 803530565 | 06912547394358 | On the market | |
| Iliac Screws 803531005 | 803531005 | 06912547394327 | On the market | |
| Iliac Screws 803531065 | 803531065 | 06912547394242 | On the market | |
| Iliac Screws 803531070 | 803531070 | 06912547394259 | On the market | |
| Iliac Screws 803537500 | 803537500 | 06912547393900 | On the market | |
| Iliac Screws 803537560 | 803537560 | 06912547393863 | On the market | |
| Iliac Screws 803537590 | 803537590 | 06912547393887 | On the market | |
| Iliac Screws 803538065 | 803538065 | 06912547393924 | On the market | |
| Iliac Screws 803538560 | 803538560 | 06912547393962 | On the market | |
| Iliac Screws 803539005 | 803539005 | 06912547394105 | On the market | |
| Iliac Screws 803539010 | 803539010 | 06912547394112 | On the market | |
| Iliac Screws 803539065 | 803539065 | 06912547394020 | On the market | |
| Iliac Screws 803539580 | 803539580 | 06912547394167 | On the market | |
| Multi-Axial Reduction Screw 8228050 | 8228050 | 06912547393351 | On the market | |
| Multi-Axial Reduction Screw 8228525 | 8228525 | 06912547393399 | On the market | |
| Multi-Axial Reduction Screw 8228560 | 8228560 | 06912547393467 | On the market | |
| Multi-Axial Screw 8218025 | 8218025 | 06912547393122 | On the market | |
| Multi-Axial Screw 8218055 | 8218055 | 06912547393184 | On the market | |
| Multi-Axial Screw 8218060 | 8218060 | 06912547393191 | On the market | |
| Multi-Axial Screw 8218555 | 8218555 | 06912547393276 | On the market | |
| Pedicle Hook 803920001 | 803920001 | 06912547395065 | On the market | |
| Planar Reduction Screw 803604535 | 803604535 | 06912547393511 | On the market | |
| Planar Reduction Screw 803604540 | 803604540 | 06912547393535 | On the market | |
| Planar Reduction Screw 803605525 | 803605525 | 06912547393641 | On the market | |
| Planar Reduction Screw 803605530 | 803605530 | 06912547393658 | On the market | |
| Planar Reduction Screw 803605550 | 803605550 | 06912547393696 | On the market | |
| Planar Reduction Screw 803606030 | 803606030 | 06912547393726 | On the market | |
| Planar Reduction Screw 803606035 | 803606035 | 06912547393733 | On the market | |
| Planar Reduction Screw 803606545 | 803606545 | 06912547395201 | On the market | |
| Planar Reduction Screw 803607030 | 803607030 | 06912547395263 | On the market | |
| Planar Reduction Screw 803607050 | 803607050 | 06912547395300 | On the market | |
| Planar Reduction Screw 803607525 | 803607525 | 06912547395348 | On the market | |
| Planar Reduction Screw 803607530 | 803607530 | 06912547395355 | On the market | |
| Reduction Pedicle Hook 803930001 | 803930001 | 06912547395164 | On the market | |
| Straight Connection Rod 803795040 | 803795040 | 06912547394709 | On the market | |
| Transverse Process Hook 803920003 | 803920003 | 06912547395089 | On the market | |
| Wide Pedicle Hook 800460007 | 800460007 | 06912547395096 | On the market |
Similar devices
Other devices filed under FDA product code NKB (Thoracolumbosacral Pedicle Screw System).
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- VADER Pedicle System, K-wire, Nitinol, Ø 1.1 × 472 mm 42-542 by icotec AG
- GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System by Greens Surgicals Pvt., Ltd.
- Erisma®-LP 13028580 by Clariance, Inc.
- CD HORIZON SPINAL SYSTEM by MEDTRONIC SOFAMOR DANEK, INC.
- Everest Spinal System by K2M, INC.
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