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

Burr, Orthopedic

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

HTT is the FDA product code for Burr, Orthopedic, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 23 recalls.

Classification record

Product code
HTT
Device name
Burr, Orthopedic
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
4
Ingested recalls
23

Clearances, product code HTT

By decision year
4 clearances under product code HTT with a decision year between 1976 and 1986, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HTT by decision year
YearClearances
19761
19801
19821
19861

Applicants with the most clearances

Product code HTT
Applicants holding the most 510(k) clearances under product code HTT
ApplicantClearances
Cutter Laboratories, Inc.1
Hall Surgical, Division of Zimmer, Inc.1
Micro-Aire Surgical Instruments, Inc.1
The Anspach Effort, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 89 companies shown, in name order