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

Table, Surgical With Orthopedic Accessories, Ac-Powered

21 CFR 878.4960 / General, Plastic Surgery
FDA source (opens on fda.gov)

JEA is the FDA product code for Table, Surgical With Orthopedic Accessories, Ac-Powered, a class I device type, regulated under 21 CFR 878.4960. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 41 recalls.

Classification record

Product code
JEA
Device name
Table, Surgical With Orthopedic Accessories, Ac-Powered
Regulation
21 CFR 878.4960
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
10
Ingested recalls
41

Clearances, product code JEA

By decision year
10 clearances under product code JEA with a decision year between 1987 and 1995, 1987 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JEA by decision year
YearClearances
19873
19881
19891
19901
19912
19931
19951

Applicants with the most clearances

Product code JEA
Applicants holding the most 510(k) clearances under product code JEA
ApplicantClearances
Andronic Devices, Ltd.4
Mizuho Orthopedic Systems Inc2
M.D. Intl., Inc.1
Mend Technologies, Inc.1
Skytron, LLC1
Stryker Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order