Pass LP Spinal System
FDA 510(k) K083810 · Medicrea Technologies
510(k) numberK083810
Submission
- Device name
- Pass LP Spinal System
- Applicant
- Medicrea Technologies
Round Rock, TX, US - Received
- December 22, 2008
- Decision date
- July 31, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MNI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171497 | Mikron Spinal Fixation SystemMNI · Traditional | Mikron Makina Sanayi Ticaret Co. , Ltd. | 10/12/2017SE |
| K160731 | LumFix Spinal Fixation SytemMNI · Traditional | CG Bio Co., Ltd. | 10/04/2016SE |
| K151458 | Double Medical Universal Spine SystemMNI · Traditional | Double Medical Technology, Inc. | 08/22/2016SE |
| K153273 | MySpine Pedicle Screw Placement Guides - LPMNI · Traditional | Medacta International S.A. | 06/29/2016SE |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemMNI · Special | Spinevision S.A. | 04/04/2016SE |
| K160320 | PremierMNI · Traditional | Shandong Weigao Orthopaedic Device Co., Ltd. | 04/01/2016SE |
| K160003 | Sniper (R) Spine SystemMNI · Traditional | Spine Wave, Inc. | 02/26/2016SE |
| K152324 | YAHUA Spinal SystemMNI · Traditional | Beijing Weigao Yahua Artificial Joint… | 02/01/2016SE |
| K143222 | FIREFLY Pedicle Screw Navigation GuideMNI · Traditional | Mighty Oak Medical, Inc. | 12/11/2015SE |
| K150684 | WASTON General Spinal SystemMNI · Traditional | Changzhou Waston Medical Appliance Co., Ltd. | 11/18/2015SE |
More from Changzhou Waston Medical Appliance Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K102406 | Pass Anterior Spinal SystemKWQ · Traditional | 08/23/2011SE |
| K100544 | Impix Lumbar Interbody DeviceMAX · Special | 07/22/2010SE |
| K083798 | Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMAX · Traditional | 05/19/2010SE |
| K100297 | Pass LP Spinal SystemMNI · Traditional | 03/04/2010SE |
| K083308 | Pass LP Spinal SystemMNI · Special | 12/10/2008SE |
| K082577 | Pass LP Spinal SystemMNH · Special | 10/03/2008SE |
| K082069 | Pass 2 Spinal SystemMNI · Special | 10/03/2008SE |
| K080099 | Pass Spinal SystemMNI · Special | 04/09/2008SE |
| K072226 | Impix SpacerMAX · Traditional | 12/10/2007SE |
| K070530 | Modification to Passmed Spinal SystemMNH · Special | 10/18/2007SE |
Questions and answers
When was Pass LP Spinal System cleared by the FDA?
Pass LP Spinal System (K083810) received a 510(k) decision of Substantially Equivalent on July 31, 2009, 221 days after the submission was received.
What is the product code of K083810?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.