510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
JXIClass II

Cuff, Nerve

21 CFR 882.5275 / Neurology
FDA source (opens on fda.gov)

JXI is the FDA product code for Cuff, Nerve, a class II device type, regulated under 21 CFR 882.5275. As of , FDA records hold 40 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
JXI
Device name
Cuff, Nerve
Regulation
21 CFR 882.5275
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
40
Ingested recalls
4

Clearances, product code JXI

By decision year
40 clearances under product code JXI with a decision year between 1985 and 2026, 2025 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JXI by decision year
YearClearances
19851
19991
20001
20012
20032
20041
20051
20061
20101
20111
20121
20143
20151
20163
20173
20181
20191
20201
20222
20233
20243
20254
20262

Applicants with the most clearances

Product code JXI
Applicants holding the most 510(k) clearances under product code JXI
ApplicantClearances
Alafair Biosciences, Inc.4
Collagen Matrix, Inc4
Integra LifeSciences Corporation4
Axogen Corporation3
Polyganics B.V.3
Biocircuit Technologies2
Cook Biotech Incorporated2
Medovent GmbH2
Salumedica, LLC2
Auxilium Biotechnologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 32 companies shown, in name order