Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)— 510(k) K200290
Substantially EquivalentSeaSpine Orthopedics Corporation
FDA 510(k) clearance K200290 for Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT), Substantially Equivalent on 2020-05-11. Applicant: SeaSpine Orthopedics Corporation. Device class: 2.
Clearance details
- Applicant
- SeaSpine Orthopedics Corporation
- 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
- Irvine, CA, US
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More clearances from SeaSpine Orthopedics Corporation
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.