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

Bit, Drill

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

HTW is the FDA product code for Bit, Drill, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 114 recalls.

Classification record

Product code
HTW
Device name
Bit, Drill
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
11
Ingested recalls
114

Clearances, product code HTW

By decision year
11 clearances under product code HTW with a decision year between 1982 and 2016, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HTW by decision year
YearClearances
19821
19831
19842
19861
19871
19891
19921
19931
19941
20161

Applicants with the most clearances

Product code HTW
Applicants holding the most 510(k) clearances under product code HTW
ApplicantClearances
Bowen & Company, Inc.1
Hand Biomechanics Lab Inc1
Kenneth J. Hoek, M.D., Inc.1
Medical Specialists in Packaging1
Mitek Surgical Products, Inc.1
Neoligaments, Ltd.1
Ortho Pared Instruments, Inc.1
Plastafil, Inc.1
Renovo Life, LLC1
Standard Surgical1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 507 companies shown, in name order