Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant
FDA 510(k) K082795 · Interventional Spine, Inc.
510(k) numberK082795
Submission
- Device name
- Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant
- Applicant
- Interventional Spine, Inc.
Irvine, CA, US - Received
- September 23, 2008
- Decision date
- December 12, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRW – System, Facet Screw Spinal Device
- Device class
- Unclassified
- Implant
- Yes
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| K250920 | Arthrex Spine Compression FT ScrewMRW · Traditional | Arthrex, Inc. | 05/22/2025SE |
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| K152156 | Opticage Expandable Interbody Fusion DeviceMAX · Traditional | 10/19/2015SE |
| K140716 | Opticage Expandable Interbody Fusion DeviceMAX · Traditional | 11/24/2014SE |
| K133583 | Opticage Interbody Fusion Device, Model Series 9070MAX · Special | 02/10/2014SE |
| K132479 | Opticage Interbody Fusion Device, Model 9080-00MAX · Special | 09/19/2013SE |
| K113527 | Opticage Interbody Fusion DeviceMAX · Traditional | 01/20/2012SE |
| K090767 | Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerMRW · Special | 06/11/2009SESU |
Questions and answers
When was Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant cleared by the FDA?
Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant (K082795) received a 510(k) decision of Substantially Equivalent on December 12, 2008, 80 days after the submission was received.
What is the product code of K082795?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.