510(k) K242050

Montage Settable Bone Putty by Orthocon, Inc. — Product Code MQV

K242050 is an FDA 510(k) premarket notification submitted by Orthocon, Inc. for the device "Montage Settable Bone Putty". The FDA issued a decision of Substantially Equivalent on July 29, 2024. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Orthocon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2024
Date Received
July 12, 2024
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