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

Trephine

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

HWK is the FDA product code for Trephine, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
HWK
Device name
Trephine
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
1
Ingested recalls
0

Clearances, product code HWK

By decision year
1 clearance under product code HWK with a decision year between 1985 and 1985, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HWK by decision year
YearClearances
19851

Applicants with the most clearances

Product code HWK
Applicants holding the most 510(k) clearances under product code HWK
ApplicantClearances
Concept, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 120 companies shown, in name order