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

Methyl Methacrylate For Cranioplasty

21 CFR 882.5300 / Neurology
FDA source (opens on fda.gov)

GXP is the FDA product code for Methyl Methacrylate For Cranioplasty, a class II device type, regulated under 21 CFR 882.5300. As of , FDA records hold 45 510(k) clearances under this code, the most recent dated , and 30 recalls.

Classification record

Product code
GXP
Device name
Methyl Methacrylate For Cranioplasty
Regulation
21 CFR 882.5300
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
45
Ingested recalls
30

Clearances, product code GXP

By decision year
45 clearances under product code GXP with a decision year between 1987 and 2026, 2004 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GXP by decision year
YearClearances
19871
19961
19971
19983
19992
20001
20011
20024
20034
20045
20052
20064
20073
20091
20101
20151
20171
20191
20232
20242
20264

Applicants with the most clearances

Product code GXP
Applicants holding the most 510(k) clearances under product code GXP
ApplicantClearances
Orthocon, Inc.7
Stryker Corp.5
Synthes (USA) Products LLC5
Zimmer GmbH4
Skeletal Kinetics, LLC3
Doctor'S Research Group, Inc.2
Etex Corp.2
Osteogenics, Inc.2
Cardinalhealth1
Cerenovus, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order