510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010786Substantially Equivalent

Ulnar Head Implant

Avanta Orthopaedics, Inc., San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010786 is the FDA 510(k) clearance record for ULNAR HEAD IMPLANT, a class II device, cleared for Avanta Orthopaedics, Inc. on under FDA product code KXE (Prosthesis, Wrist, Hemi-, Ulnar). FDA records list 18 510(k) clearances for Avanta Orthopaedics, Inc., from to . As of , FDA records show one recall naming K010786.

Clearance record

Decision date
Received
(27 days to decision)
Product code
KXE Prosthesis, Wrist, Hemi-, Ulnar
Regulation
21 CFR 888.3810
Device class
Class II
Review panel
Orthopedic
Applicant
Avanta Orthopaedics, Inc. 9369 Carroll Park Dr., Suite A, San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code KXE

Trailing 12 months

FDA records hold no clearances under product code KXE in the trailing twelve months.

FDA records show no clearances under product code KXE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260