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

Cranial Surgical Planning And Instrument Guides

21 CFR 882.4310 / Neurology
FDA source (opens on fda.gov)

PPT is the FDA product code for Cranial Surgical Planning And Instrument Guides, a class II device type, regulated under 21 CFR 882.4310. FDA's definition for this code reads: "Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PPT
Device name
Cranial Surgical Planning And Instrument Guides
FDA definition
Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures.
Regulation
21 CFR 882.4310
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code PPT

By decision year
4 clearances under product code PPT with a decision year between 2016 and 2026, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PPT by decision year
YearClearances
20161
20191
20201
20261

Applicants with the most clearances

Product code PPT
Applicants holding the most 510(k) clearances under product code PPT
ApplicantClearances
KLS-Martin L.P.2
3D Systems, Inc.1
Materialise N.V.1

Companies listing this code with FDA

Companies whose registered establishments list this code