510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954915Substantially Equivalent

Flexible Intramedullary Reamer

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954915 is the FDA 510(k) clearance record for FLEXIBLE INTRAMEDULLARY REAMER, a class I device, cleared for Zimmer, Inc. on under FDA product code HTO (Reamer). FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K954915.

Clearance record

Decision date
Received
(63 days to decision)
Product code
HTO Reamer
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Zimmer, Inc. P.O. Box 708, Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code HTO

Trailing 12 months

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

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