510(k) K193040
K193040 is an FDA 510(k) premarket notification submitted by SeaSpine Orthopedics Corporation for the device "Resorbable Mesh Device". The FDA issued a decision of Substantially Equivalent on Nov 30, 2019. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. SeaSpine Orthopedics Corporation has 66 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 30, 2019
- Date Received
- Oct 31, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filler, Bone Void, Calcium Compound
- Device Class
- Class II
- Regulation Number
- 888.3045
- Review Panel
- OR
- Submission Type
- 510(k)