Rsb Spine, LLC
FDA Regulatory Profile
Rsb Spine, LLC has 0 FDA recalls, 6 inspections, 7 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jul 28, 2025 · NAI
- Latest 510(k)
- Jan 27, 2010
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 7 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 6 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jul 28, 2025 | Wooster, OH | Devices | No Action Indicated (NAI) | 3003597504 |
| Dec 21, 2017 | Wooster, OH | Devices | Voluntary Action Indicated (VAI) | 3003597504 |
| Dec 4, 2014 | Wooster, OH | Devices | No Action Indicated (NAI) | 3003597504 |
| Aug 6, 2013 | Wooster, OH | Devices | Voluntary Action Indicated (VAI) | 3003597504 |
| Dec 13, 2011 | Wooster, OH | Biologics | No Action Indicated (NAI) | 3003597504 |
| May 21, 2010 | Wooster, OH | Devices | No Action Indicated (NAI) | 3003597504 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3003597504 | Wooster, OH | 6 | Jul 28, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K092540 | C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER | Jan 27, 2010 |
| K092070 | INTERPLATE C | Oct 6, 2009 |
| K081194 | INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) | May 29, 2008 |
| K071922 | INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC | Sep 18, 2007 |
| K071372 | MODIFICATION TO: INTERPLATE VBR SYSTEM | Jun 11, 2007 |
| K070316 | INTERPLATE VBR SYSTEM | Apr 19, 2007 |
| K061401 | INTERPLATE VBR SYSTEM | Aug 18, 2006 |