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

Washer, Bolt Nut

21 CFR 888.3030 / Orthopedic
FDA source (opens on fda.gov)

HTN is the FDA product code for Washer, Bolt Nut, a class II device type, regulated under 21 CFR 888.3030. As of , FDA records hold 93 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
HTN
Device name
Washer, Bolt Nut
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
93
Ingested recalls
4

Clearances, product code HTN

By decision year
93 clearances under product code HTN with a decision year between 1984 and 2026, 2014 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code HTN by decision year
YearClearances
19842
19871
19881
19891
19914
19931
19941
19963
19971
19984
19992
20011
20023
20031
20041
20054
20061
20071
20082
20093
20114
20133
20148
20152
20161
20176
20182
20195
20203
20212
20225
20232
20246
20254
20262

Applicants with the most clearances

Product code HTN
Applicants holding the most 510(k) clearances under product code HTN
ApplicantClearances
Arthrex GmbH16
Dallen Medical, Inc.5
Synthes (USA) Products LLC5
Acu Med, Inc.4
Acumed LLC4
Akros Medical3
Buckman Co., Inc.3
Instratek, Inc.3
Arthrosurface, Inc.2
ConMed Corporation2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 226 companies shown, in name order