Pedicle Hook 803920001
by Shandong Weigao Orthopaedic Device Co., Ltd.
Pedicle Hook 803920001 is a Class II device made by Shandong Weigao Orthopaedic Device Co., Ltd., cleared under FDA 510(k) K170861 on 4 Aug 2017 and listed in FDA GUDID since 12 Dec 2017 (UDI-DI 06912547395065), 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 | GUDID listing | Number06912547395065 | Date12 Dec 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170861 | Date4 Aug 2017 | StatusActive |
Official records
- AccessGUDID record 06912547395065
- FDA 510(k) database K170861
Across registries
- FDA 510(k) K170861 decided 4 Aug 2017 Active
- FDA GUDID UDI-DI 06912547395065 listed 12 Dec 2017 Listed
Timeline
- Cleared FDA 510(k) K170861
- Listed FDA GUDID 06912547395065
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pedicle Hook
- Generic name
- Bone-screw internal spinal fixation system hook
- Model / reference
- 803920001
- Primary DI / UDI-DI
- 06912547395065
- 510(k) Number
- FDA product code
- KWP, NKB
- GMDN term
- Bone-screw internal spinal fixation system hook
- Device class
- Class II
- Regulation number
- 888.3050, 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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