510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K061146Substantially Equivalent

Sbi Ulnar Head Implant

Small Bone Innovations, Inc., New York NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061146 is the FDA 510(k) clearance record for SBI ULNAR HEAD IMPLANT, a class II device, cleared for Small Bone Innovations, Inc. on under FDA product code KXE (Prosthesis, Wrist, Hemi-, Ulnar). FDA records list 24 510(k) clearances for Small Bone Innovations, Inc., from to . As of , FDA records show 2 recalls naming K061146.

Clearance record

Decision date
Received
(85 days to decision)
Product code
KXE Prosthesis, Wrist, Hemi-, Ulnar
Regulation
21 CFR 888.3810
Device class
Class II
Review panel
Orthopedic
Applicant
Small Bone Innovations, Inc. 505 Park Ave. 14th Floor, New York NY
510(k) summary
Summary PDF
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