Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
FDA 510(k) K171456 · Choicespine
510(k) numberK171456
Submission
- Device name
- Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
- Applicant
- Choicespine
Knoxville, TN, US - Received
- May 17, 2017
- Decision date
- August 3, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
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| K253045 | Socko Vimax Spinal Fixation SystemNKB · Traditional | Socko Medical Co., Ltd. | 06/17/2026SE |
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| K260989 | Varion Thoracolumbar Fixation SystemNKB · Traditional | Kyocera Medical Technologies Inc. (KMTI) | 05/15/2026SE |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional | Globus Medical, Inc. | 05/07/2026SE |
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Questions and answers
When was Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems cleared by the FDA?
Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems (K171456) received a 510(k) decision of Substantially Equivalent on August 3, 2017, 78 days after the submission was received.
What is the product code of K171456?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.