510(k) K263116

OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts by OsteoCentric Technologies — Product Code HWC

K263116 is an FDA 510(k) premarket notification submitted by OsteoCentric Technologies for the device "OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts". The FDA issued a decision of Substantially Equivalent on Oct 2, 2026. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. OsteoCentric Technologies has 12 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 2, 2026
Date Received
Sep 4, 2026
Clearance Type
Special
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
510(k)

Source: FDA 510(k) database entry for K263116. Report a data issue: hello@regdatalab.com.