510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023770Substantially Equivalent

K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)

Kinetikos Medical, Inc., San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023770 is the FDA 510(k) clearance record for K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM), a class II device, cleared for Kinetikos Medical, Inc. on under FDA product code KWD (Prosthesis, Toe, Hemi-, Phalangeal). FDA records list 19 510(k) clearances for Kinetikos Medical, Inc., from to . As of , FDA records show no recalls naming K023770.

Clearance record

Decision date
Received
(30 days to decision)
Product code
KWD Prosthesis, Toe, Hemi-, Phalangeal
Regulation
21 CFR 888.3730
Device class
Class II
Review panel
Orthopedic
Applicant
Kinetikos Medical, Inc. 4115 Sorrento Valley Blvd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWD

Trailing 12 months
1 clearance under product code KWD in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260