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

Prosthesis, Finger, Constrained, Polymer

21 CFR 888.3230 / Orthopedic
FDA source (opens on fda.gov)

KYJ is the FDA product code for Prosthesis, Finger, Constrained, Polymer, a class II device type, regulated under 21 CFR 888.3230. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
KYJ
Device name
Prosthesis, Finger, Constrained, Polymer
Regulation
21 CFR 888.3230
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
14
Ingested recalls
4

Clearances, product code KYJ

By decision year
14 clearances under product code KYJ with a decision year between 1978 and 2023, 2002 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KYJ by decision year
YearClearances
19781
19791
19871
19941
19971
20001
20022
20092
20151
20221
20232

Applicants with the most clearances

Product code KYJ
Applicants holding the most 510(k) clearances under product code KYJ
ApplicantClearances
Ascension Orthopedics, Inc.3
Depuy, Inc.2
Avanta Orthopaedics, Inc.1
BRM Extremities SRL1
Cutter Laboratories, Inc.1
Depuy Orthopaedics Inc.1
Farah, Ltd.1
Keri Medical1
Osteotec Limited1
Sutter Biomedical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order