Identity
- Trade Name
- LANCER/THUNDERBOLT Pedicle Screw System FDA UDI
- Generic Name
- Spinal guidewire FDA UDI
- Device Name
- T'BOLT,KWIRE,SS,BLUNT-TROCAR,LASER,22 FDA UDI
- Model / Reference
- M070-LS222 FDA UDI
- Description
- T'BOLT,KWIRE,SS,BLUNT-TROCAR,LASER,22 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840996173858 FDA UDI
- 510(k) Number
- K132049 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Spinal guidewire 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: Spinal guidewire
LANCER/THUNDERBOLT Pedicle Screw System by Choicespine, LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal guidewire.
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- Cortera — Xtant Medical Holdings, Inc. · Class I
- Cortera — Xtant Medical Holdings, Inc. · Class I
- RAVINE® Lateral Access System — K2M, INC. · Class I
- NILE™ Spinal System — K2M, INC. · Class II
- MEGA PLUS MIS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- DeGen Standard Instrumentation — Degen Medical · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
Cleared under the same submission
K132049 also covers:
- LANCER Pedicle Screw System — Choicespine, LP
- LANCER Pedicle Screw System — Choicespine, LP
- LANCER Pedicle Screw System — Choicespine, LP
- LANCER Pedicle Screw System — Choicespine, LP
- LANCER Pedicle Screw System — Choicespine, LP
- LANCER Pedicle Screw System — Choicespine, LP
- LANCER™ Pedicle Screw System — Choicespine, LP
- LANCER™ Pedicle Screw System — Choicespine, LP
- LANCER™ Pedicle Screw System — Choicespine, LP
- LANCER™ Pedicle Screw System — Choicespine, LP
- LANCER™ Pedicle Screw System — Choicespine, LP
- LANCER™ Pedicle Screw System — 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 |
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Manufacturer
- Manufacturer
- Choicespine, LP
Sources (1)
- FDA UDI 66d378b0-1067-4acf-a47f-082125935186 35 fields · synced May 30, 2026