510(k) K242273

Cove Putty, OsteoCove Putty by SeaSpine Orthopedics Corporation — Product Code MQV

K242273 is an FDA 510(k) premarket notification submitted by SeaSpine Orthopedics Corporation for the device "Cove Putty, OsteoCove Putty". The FDA issued a decision of Substantially Equivalent on September 25, 2024. 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2024
Date Received
August 1, 2024
Clearance Type
Traditional
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