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THUNDERBOLT Minimally Invasive Pedicle Screw System
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- THUNDERBOLT Minimally Invasive Pedicle Screw System FDA UDI
- Generic Name
- Orthopaedic rod reducer FDA UDI
- Device Name
- THUNDERBOLT,EXTERNAL REDUCER FDA UDI
- Model / Reference
- M070-0129 FDA UDI
- Description
- THUNDERBOLT,EXTERNAL REDUCER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840996175036 FDA UDI
- 510(k) Number
- K171456 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic rod reducer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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: Orthopaedic rod reducer
THUNDERBOLT Minimally Invasive Pedicle Screw System by Choicespine, LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic rod reducer.
- MONUMENT — GLOBUS MEDICAL, INC. · Class I
- Golden Isles Pedicle Screw System — Intelivation, LLC · Class II
- ReLine — Nuvasive, Inc. · Class I
- Mariner MCT — SeaSpine Orthopedics Corporation · Class I
- PERLA ® — Spineart · Class II
- Prodigy Pedicle Screw System — Curiteva, LLC · Class II
- PERLA ® — Spineart · Class II
- ReLine — Nuvasive, Inc. · Class I
Cleared under the same submission
K171456 also covers:
- LANCER Pedicle Screw System — Choicespine, LP
- LANCER Pedicle Screw System — Choicespine, LP
- LANCER Pedicle Screw System — Choicespine, LP
- Lancer — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Choicespine, LP
Sources (1)
- FDA UDI fe685281-86b1-4f18-aab4-17a46a743a3e 35 fields · synced Jun 8, 2026