PRECICE Plating System
FDA 510(k) K192181 · Nuvasive Specialized Orthopedics, Inc.
510(k) numberK192181
Submission
- Device name
- PRECICE Plating System
- Applicant
- Nuvasive Specialized Orthopedics, Inc.
Alisa Viejo, CA, US - Received
- August 12, 2019
- Decision date
- November 7, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | Synthes (USA) Products, LLC | 06/11/2026SE |
| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261651 | Precice Max System and Precice Ankle Salvage SystemHSB · Special | 06/18/2026SE |
| K233593 | MAGEC Spinal Bracing and Distraction SystemPGN · Traditional | 02/06/2024SE |
| K232267 | Precice Max SystemHSB · Traditional | 12/15/2023SE |
| K230765 | Precice Ankle Salvage SystemHSB · Traditional | 08/29/2023SE |
| K220234 | Precice Intramedullary Limb Lengthening SystemHSB · Traditional | 03/15/2023SE |
| K202348 | External Remote Controller ERC 4PHSB · Traditional | 12/22/2020SE |
| K200430 | Precice® Ankle Salvage SystemHSB · Traditional | 09/16/2020SE |
| K201567 | Precice® Bone Transport SystemHSB · Traditional | 08/10/2020SE |
| K201543 | MAGEC® SystemPGN · Traditional | 07/30/2020SE |
| K193617 | Precice® ScrewsHSB · Traditional | 05/08/2020SE |
Questions and answers
When was PRECICE Plating System cleared by the FDA?
PRECICE Plating System (K192181) received a 510(k) decision of Substantially Equivalent on November 7, 2019, 87 days after the submission was received.
What is the product code of K192181?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.