Identity
- Trade Name
- Royal Oak Pedicle Screw System FDA UDI
- Generic Name
- External spinal fixation system FDA UDI
- Device Name
- Royal Oak Pedicle Screw Instrument Set Case 1 FDA UDI
- Model / Reference
- 4301081 FDA UDI
- Description
- Royal Oak Pedicle Screw Instrument Set Case 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812352021301 FDA UDI
- 510(k) Number
- K110046 FDA UDI
- FDA Product Code
- MNI FDA UDINKB FDA UDIMNH FDA UDI
- GMDN Term
- External spinal fixation system 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
Yes
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: External spinal fixation system
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 External spinal fixation system.
- Fang Plate — EMINENT SPINE LLC · Class II
- MLX — Nuvasive, Inc. · Class I
- 4CIS® INSTRUMENT SYSTEM — ALPHANOX CO., LTD. · Class I
- King Cobra — EMINENT SPINE LLC · Class II
- NuVasive — Nuvasive, Inc. · Class I
- King Cobra — EMINENT SPINE LLC · Class II
- 4CIS® INSTRUMENT SYSTEM — ALPHANOX CO., LTD. · Class I
- Fang Plate — EMINENT SPINE LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Royal Oak Medical Devices
Sources (1)
- FDA UDI 65012e35-d54b-4b53-b0bd-dae9fc369c23 35 fields · synced May 31, 2026