Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer
FDA 510(k) K090767 · Interventional Spine, Inc.
510(k) numberK090767
Submission
- Device name
- Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer
- Applicant
- Interventional Spine, Inc.
Irvine, CA, US - Received
- March 23, 2009
- Decision date
- June 11, 2009
- Decision
- Unknown (SESU)
- Type
- Special 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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| K251714 | Ion-CMRW · Traditional | SurGenTec, LLC | 01/16/2026SE |
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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 |
| K082795 | Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantMRW · Traditional | 12/12/2008SE |
Questions and answers
When was Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer cleared by the FDA?
Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer (K090767) received a 510(k) decision of Unknown on June 11, 2009, 80 days after the submission was received.
What is the product code of K090767?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.