510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915776Substantially Equivalent

Knee Prosthesis Driver

Kim-Med, Inc., Kansas City MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915776 is the FDA 510(k) clearance record for KNEE PROSTHESIS DRIVER, a class I device, cleared for Kim-Med, Inc. on under FDA product code HWR (Driver, Prosthesis). FDA records list one 510(k) clearance for Kim-Med, Inc. As of , FDA records show no recalls naming K915776.

Clearance record

Decision date
Received
(170 days to decision)
Product code
HWR Driver, Prosthesis
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Kim-Med, Inc. 1407 Kansas Ave., Kansas City MO
510(k) summary
Statement
Third party review
No

Clearances, product code HWR

Trailing 12 months

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

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