INTERPLATE C— 510(k) K092070
Substantially EquivalentRsb Spine, LLC
FDA 510(k) clearance K092070 for INTERPLATE C, Substantially Equivalent on 2009-10-06. Applicant: Rsb Spine, LLC. Device class: 2.
Clearance details
- Applicant
- Rsb Spine, LLC
- Product code
- Code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chesterland, OH, US
Recent devices under product code KWQ
view allMore clearances from Rsb Spine, LLC
view all- K092540 — C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
- K081194 — INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)
- K071922 — INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC
- K071372 — MODIFICATION TO: INTERPLATE VBR SYSTEM
- K070316 — INTERPLATE VBR SYSTEM
Adverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.