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

Template

21 CFR 888.4800 / Orthopedic
FDA source (opens on fda.gov)

HWT is the FDA product code for Template, a class I device type, regulated under 21 CFR 888.4800. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 85 recalls.

Classification record

Product code
HWT
Device name
Template
Regulation
21 CFR 888.4800
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
10
Ingested recalls
85

Clearances, product code HWT

By decision year
10 clearances under product code HWT with a decision year between 1977 and 1998, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HWT by decision year
YearClearances
19772
19781
19811
19831
19872
19901
19971
19981

Applicants with the most clearances

Product code HWT
Applicants holding the most 510(k) clearances under product code HWT
ApplicantClearances
Depuy, Inc.2
3M Company1
Zimmer GmbH1
Integrated Surgical Systems, Inc.1
Kronner Medical1
Ortho-Graphics, Inc.1
Mizuho Orthopedic Systems Inc1
Shannon Group1
Warsaw Orthopedic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 395 companies shown, in name order