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

Reamer

21 CFR 888.4540 / Orthopedic
FDA source (opens on fda.gov)

HTO is the FDA product code for Reamer, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 83 recalls.

Classification record

Product code
HTO
Device name
Reamer
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
14
Ingested recalls
83

Clearances, product code HTO

By decision year
14 clearances under product code HTO with a decision year between 1977 and 2011, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HTO by decision year
YearClearances
19771
19792
19811
19831
19861
19871
19891
19901
19951
20001
20011
20051
20111

Applicants with the most clearances

Product code HTO
Applicants holding the most 510(k) clearances under product code HTO
ApplicantClearances
Synthes (USA) Products LLC4
Depuy, Inc.2
3M Company1
Hirata Sangyo Co. USA, Inc.1
Instrumentation Industries, Incorporated1
Mcconnell Orthopedic1
Onyx Medical LLC1
The Anspach Effort, Inc.1
Warsaw Orthopedic, Inc.1
Zimmer GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 323 companies shown, in name order