Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
cranial surgical planning and instrument guides
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.
Product Code
PPT
Regulation Number
882.4310
Device Class
2
Premarket Reviews
Manufacturer
Decision
3D SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
KLS-MARTIN L.P.
SUBSTANTIALLY EQUIVALENT
2
1. K182889
KLS Martin Individual Patient Solutions (IPS) Plan
...
2. K201052
KLS Martin Individual Patient Solutions (IPS) Plan
...
-
-