REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1— 510(k) K082419
Substantially EquivalentIntra-Lock International, Inc.
FDA 510(k) clearance K082419 for REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1, Substantially Equivalent on 2009-05-27. Applicant: Intra-Lock International, Inc..
Clearance details
- Applicant
- Intra-Lock International, Inc.
- Product code
- Code MQV
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Boca Raton, FL, US
Adverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
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.