Rsb Spine, LLC: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Rsb Spine, LLC” (first 2006, latest 2010), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 77 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Rsb Spine, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092540 | C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER | ODP | 2010-01-27 | 161 |
| K092070 | INTERPLATE C | KWQ | 2009-10-06 | 90 |
| K081194 | INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) | OVE | 2008-05-29 | 31 |
| K071922 | INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC | OVD | 2007-09-18 | 68 |
| K071372 | MODIFICATION TO: INTERPLATE VBR SYSTEM | MQP | 2007-06-11 | 26 |
| K070316 | INTERPLATE VBR SYSTEM | MQP | 2007-04-19 | 77 |
| K061401 | INTERPLATE VBR SYSTEM | MQP | 2006-08-18 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Rsb Spine, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Rsb Spine, LLC?
FDA lists 7 510(k) clearances under the applicant name “Rsb Spine, LLC” (first 2006, latest 2010), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rsb Spine, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rsb Spine, LLC is 77 days.
Which FDA product codes appear under Rsb Spine, LLC?
The most frequent FDA product codes under this applicant name are MQP (Spinal Vertebral Body Replacement Device, 3); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 1).
Next steps
- See all 7 Rsb Spine, LLC clearances with predicates and recalls
- Run predicate analysis for product code MQP, Rsb Spine, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.