PRECICE UNYTE CoCr System
FDA 510(k) K162927 · Nuvasive Specialized Orthopedics, Inc.
510(k) numberK162927
Submission
- Device name
- PRECICE UNYTE CoCr System
- Applicant
- Nuvasive Specialized Orthopedics, Inc.
Alisa Viejo, CA, US - Received
- October 19, 2016
- Decision date
- April 6, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | Stryker GmbH | 06/29/2026SE |
| K261651 | Precice Max System and Precice Ankle Salvage SystemHSB · Special | NuVasive Specialized Orthopedics | 06/18/2026SE |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional | Suzhou and Science & Technology Development Corp. | 06/18/2026SE |
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| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
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| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional | Orthofix Srl | 05/08/2026SE |
| K261043 | AUTOBAHN Nailing SystemHSB · Special | Globus Medical, Inc. | 04/24/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
More from Fusion Orthopedics USA, LLC
| 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 UNYTE CoCr System cleared by the FDA?
PRECICE UNYTE CoCr System (K162927) received a 510(k) decision of Substantially Equivalent on April 6, 2017, 169 days after the submission was received.
What is the product code of K162927?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.