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

Guide, Drill, Ligament

21 CFR 878.4820 / General, Plastic Surgery
FDA source (opens on fda.gov)

LXI is the FDA product code for Guide, Drill, Ligament, a class I device type, regulated under 21 CFR 878.4820. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LXI
Device name
Guide, Drill, Ligament
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code LXI

By decision year
8 clearances under product code LXI with a decision year between 1985 and 1994, 1988 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LXI by decision year
YearClearances
19851
19883
19892
19911
19941

Applicants with the most clearances

Product code LXI
Applicants holding the most 510(k) clearances under product code LXI
ApplicantClearances
Baxter Healthcare Corporation1
Dyonics, Inc.1
Instrument Makar, Inc.1
Medmetric Corp.1
Pfizer Inc1
Physio Systems, Inc.1
Silent Call Corp.1
Synvasive Technology, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 38 companies shown, in name order