Precice Intramedullary Limb Lengthening System
FDA 510(k) K133289 · Ellipse Technologies, Inc.
510(k) numberK133289
Submission
- Device name
- Precice Intramedullary Limb Lengthening System
- Applicant
- Ellipse Technologies, Inc.
Irvine, CA, US - Received
- October 25, 2013
- Decision date
- December 9, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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More from Fusion Orthopedics USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K160325 | PRECICE Intramedullary Limb Lengthening SystemHSB · Traditional | 04/04/2016SE |
| K160267 | PRECICE Trauma Nail SystemHSB · Traditional | 03/31/2016SE |
| K151594 | Ellipse Supplemental Instrument TraysKCT · Abbreviated | 01/25/2016SE |
| K152370 | PRECICE Trauma Nail SystemHSB · Special | 12/22/2015SE |
| K151131 | PRECICE Intramedullary Limb Lengthening SystemHSB · Special | 06/19/2015SE |
| K150885 | MAGEC 2 Spinal Bracing and Distraction SystemPGN · Traditional | 05/29/2015SE |
| K150656 | PRECICE Intramedullary Limb Lengthening SystemHSB · Special | 04/23/2015SE |
| K141278 | Magec Spinal Bracing and Distraction SystemPGN · Traditional | 03/24/2015SE |
| K142599 | PRECISE Trauma Nail SystemHSB · Traditional | 01/16/2015SE |
| K141739 | Residual Limb Lengthening SystemHSB · Traditional | 10/07/2014SE |
Questions and answers
When was Precice Intramedullary Limb Lengthening System cleared by the FDA?
Precice Intramedullary Limb Lengthening System (K133289) received a 510(k) decision of Substantially Equivalent on December 9, 2013, 45 days after the submission was received.
What is the product code of K133289?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.