510(k) K071922
K071922 is an FDA 510(k) premarket notification submitted by Rsb Spine, LLC for the device "INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC". The FDA issued a decision of Substantially Equivalent on Sep 18, 2007. The device falls under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar), a Class II device regulated under 21 CFR 888.3080. Rsb Spine, LLC has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 18, 2007
- Date Received
- Jul 12, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
- 510(k)
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.