Pass LP Spinal System
FDA 510(k) K082577 · Medicrea Technologies
510(k) numberK082577
Submission
- Device name
- Pass LP Spinal System
- Applicant
- Medicrea Technologies
Round Rock, TX, US - Received
- September 5, 2008
- Decision date
- October 3, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MNH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162066 | Reliance Spinal Screw SystemMNH · Traditional | Reliance Medical Systems, LLC | 12/02/2016SE |
| K162801 | CastleLoc Spinal Fixation SystemMNH · Special | L&K BIOMED Co., Ltd. | 11/03/2016SE |
| K162143 | FixxSure® X-LinkMNH · Traditional | Innovasis, Inc. | 09/23/2016SE |
| K161151 | Spinal fixation systemMNH · Traditional | Canwell Medical Co., Ltd. | 09/21/2016SE |
| K162189 | ANAX 5.5 Spinal SystemMNH · Special | U&I Corporation | 08/30/2016SE |
| K151362 | HC Spinal SystemMNH · Traditional | Hung Chun Bio-S Co., Ltd. | 05/05/2016SE |
| K153404 | Zavation Spinal SystemMNH · Traditional | Zavation, LLC | 04/21/2016SE |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | Captiva Spine | 03/02/2016SE |
| K143013 | Spinal Inner Fixation SystemMNH · Traditional | Changzhou Dingjian Medical Appliance Co., Ltd. | 12/11/2015SE |
| K151695 | Romeo posterior osteosynthesis systemMNH · Traditional | Spineart | 09/10/2015SE |
More from Spineart
| 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 |
| K083810 | Pass LP Spinal SystemMNI · Special | 07/31/2009SE |
| K083308 | Pass LP Spinal SystemMNI · Special | 12/10/2008SE |
| 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 (K082577) received a 510(k) decision of Substantially Equivalent on October 3, 2008, 28 days after the submission was received.
What is the product code of K082577?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.