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

Osteotome

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

HWM is the FDA product code for Osteotome, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HWM
Device name
Osteotome
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code HWM

By decision year
3 clearances under product code HWM with a decision year between 1977 and 1987, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HWM by decision year
YearClearances
19771
19872

Applicants with the most clearances

Product code HWM
Applicants holding the most 510(k) clearances under product code HWM
ApplicantClearances
Buckman Co., Inc.1
Depuy, Inc.1
Micro-Aire Surgical Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 239 companies shown, in name order