Identity
- Trade Name
- Royal Oak Pedicle Screw System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- 5.5mm Pedicle Screw Assembly Ø6.5x35mm FDA UDI
- Model / Reference
- PS5.5-6.5-35 FDA UDI
- Description
- 5.5mm Pedicle Screw Assembly Ø6.5x35mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812352020342 FDA UDI
- 510(k) Number
- K110046 FDA UDI
- FDA Product Code
- MNH FDA UDINKB FDA UDIMNI FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal bone screw, non-bioabsorbable
Royal Oak Pedicle Screw System by Royal Oak Medical Devices — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
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- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Cleared under the same submission
K110046 also covers:
- Royal Oak Pedicle Screw System — Royal Oak Medical Devices
- Royal Oak Pedicle Screw System — Royal Oak Medical Devices
- Royal Oak Pedicle Screw System — Royal Oak Medical Devices
- Royal Oak Pedicle Screw System — Royal Oak Medical Devices
- Royal Oak Pedicle Screw System — Royal Oak Medical Devices
- Royal Oak Pedicle Screw System — Royal Oak Medical Devices
- Royal Oak Pedicle Screw System — Royal Oak Medical Devices
- Royal Oak Pedicle Screw System — Royal Oak Medical Devices
- Royal Oak Pedicle Screw System — Royal Oak Medical Devices
- Royal Oak Pedicle Screw System — Royal Oak Medical Devices
- Royal Oak Pedicle Screw System — Royal Oak Medical Devices
- Royal Oak Pedicle Screw System — Royal Oak Medical Devices
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
- Royal Oak Medical Devices
Sources (1)
- FDA UDI 75a11239-656d-426f-9f61-a6e656dc4f73 35 fields · synced May 30, 2026