510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060038Substantially Equivalent

Sbi Radio-Capitellar Implant

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

K060038 is the FDA 510(k) clearance record for SBI RADIO-CAPITELLAR IMPLANT, a class II device, cleared for Small Bone Innovations, Inc. on under FDA product code JDB (Prosthesis, Elbow, Semi-Constrained, Cemented). FDA records list 24 510(k) clearances for Small Bone Innovations, Inc., from to . As of , FDA records show 11 recalls naming K060038.

Clearance record

Decision date
Received
(83 days to decision)
Product code
JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Regulation
21 CFR 888.3160
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 JDB

Trailing 12 months

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

FDA records show no clearances under product code JDB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDB, 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