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

Fixation Accessory

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

LYT is the FDA product code for Fixation Accessory, a class II device type, regulated under 21 CFR 888.3030. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
LYT
Device name
Fixation Accessory
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
9
Ingested recalls
4

Clearances, product code LYT

By decision year
9 clearances under product code LYT with a decision year between 1983 and 2004, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LYT by decision year
YearClearances
19831
19881
19902
19911
19921
19982
20041

Applicants with the most clearances

Product code LYT
Applicants holding the most 510(k) clearances under product code LYT
ApplicantClearances
Westcon Orthopedics, Inc.3
Chapel and Assoc.1
Horizon Medical, Inc.1
Jurgan Development & Mfg., Ltd.1
Micro-Aire Surgical Instruments, Inc.1
Osteonics Corp.1
The Jerome Group, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code