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

Prosthesis, Subtalar, Plug, Polymer

21 CFR 888.3040 / Orthopedic
FDA source (opens on fda.gov)

MJW is the FDA product code for Prosthesis, Subtalar, Plug, Polymer, a class II device type, regulated under 21 CFR 888.3040. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MJW
Device name
Prosthesis, Subtalar, Plug, Polymer
Regulation
21 CFR 888.3040
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
2
Ingested recalls
0

Clearances, product code MJW

By decision year
2 clearances under product code MJW with a decision year between 1992 and 2003, 1992 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MJW by decision year
YearClearances
19921
20031

Applicants with the most clearances

Product code MJW
Applicants holding the most 510(k) clearances under product code MJW
ApplicantClearances
Nexa Orthopedics, Inc.1
Sgarlato Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code