Montage-QS Settable, Resorbable Bone Putty— 510(k) K231903
Substantially EquivalentOrthocon, Inc.
FDA 510(k) clearance K231903 for Montage-QS Settable, Resorbable Bone Putty, Substantially Equivalent on 2023-08-25. Applicant: Orthocon, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthocon, Inc.
- Product code
- Code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
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More clearances from Orthocon, Inc.
view allAdverse 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.