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Patient-Specific Pedicle Screw Guide (FF-101-XX)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FF-PSG-0007-00
Identity
- Trade Name
- Patient-Specific Pedicle Screw Guide (FF-101-XX) EUDAMEDFIREFLY® FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- FIREFLY - Pedicle Screw Guide EUDAMEDPatient-Specific Pedicle Screw Guide FDA UDI
- Model / Reference
- FF-PSG-0007-00 EUDAMEDFF-101-XX FDA UDI
- Description
- Patient-Specific Pedicle Screw Guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851662007001 EUDAMEDFDA UDI
- Basic UDI-DI
- 0851662007FF-PSGTW EUDAMED
- FDA Product Code
- MNI FDA UDIPQC FDA UDI
- EMDN Code
- P090780 SPINAL PROSTHESES AND STABILISATION SYSTEMS - ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Market of Registration
- Slovenia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Patient-Specific Pedicle Screw Guide (FF-101-XX) by Mighty Oak Medical — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0851662007FF-PSGTW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Mighty Oak Medical
- EUDAMED SRN
- US-MF-000039584
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED ad6e6d9d-f7ed-4d73-b31d-f2e3b9b9cfc9 61 fields · synced Oct 6, 2026
- FDA UDI f4a42fed-816d-4143-8341-be6db478a471 34 fields · synced May 29, 2026