Identity
- Trade Name
- Pedicle Hook FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Model / Reference
- 803920001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06912547395065 FDA UDI
- 510(k) Number
- K170861 FDA UDI
- FDA Product Code
- KWP FDA UDINKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system hook FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-screw internal spinal fixation system hook
Pedicle Hook by Shandong Weigao Orthopaedic Device Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone-screw internal spinal fixation system hook.
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- ReLine — Nuvasive, Inc. · Class II
Cleared under the same submission
K170861 also covers:
- Closed Lateral Connector — Shandong Weigao Orthopaedic Device Co., Ltd.
- Closed Lateral Connector — Shandong Weigao Orthopaedic Device Co., Ltd.
- Closed Lateral Connector — Shandong Weigao Orthopaedic Device Co., Ltd.
- Curved Connection Rod — Shandong Weigao Orthopaedic Device Co., Ltd.
- Curved Connection Rod — Shandong Weigao Orthopaedic Device Co., Ltd.
- Curved Connection Rod — Shandong Weigao Orthopaedic Device Co., Ltd.
- Curved Connection Rod — Shandong Weigao Orthopaedic Device Co., Ltd.
- Curved Connection Rod — Shandong Weigao Orthopaedic Device Co., Ltd.
- Fixed-Angle Reduction Screw — Shandong Weigao Orthopaedic Device Co., Ltd.
- Fixed-Angle Reduction Screw — Shandong Weigao Orthopaedic Device Co., Ltd.
- Fixed-Angle Reduction Screw — Shandong Weigao Orthopaedic Device Co., Ltd.
- Fixed-Angle Screw — Shandong Weigao Orthopaedic Device Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shandong Weigao Orthopaedic Device Co., Ltd.
Sources (1)
- FDA UDI af21a307-b8aa-46c7-8939-523b2775e7a5 33 fields · synced Jun 8, 2026