510(k) K211996

Nexta PEEK Hammertoe Correction System by Nextremity Solutions, Inc. — Product Code HWC

K211996 is an FDA 510(k) premarket notification submitted by Nextremity Solutions, Inc. for the device "Nexta PEEK Hammertoe Correction System". The FDA issued a decision of Substantially Equivalent on September 23, 2021. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Nextremity Solutions, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2021
Date Received
June 28, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type