SIGNATURE PLANNER,SIGNATURE GUIDES

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Signature Planner,signature Guides.

Device ID	K111863
510k Number	K111863
Device Name:	SIGNATURE PLANNER,SIGNATURE GUIDES
Classification	Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant	MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001
Contact	Alaxandra Razzhivina
Correspondent	Alaxandra Razzhivina MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001
Product Code	JDI
Subsequent Product Code	KWY
Subsequent Product Code	KWZ
Subsequent Product Code	LPH
Subsequent Product Code	LZO
Subsequent Product Code	MAY
Subsequent Product Code	MEH
CFR Regulation Number	888.3350 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2011-06-30
Decision Date	2012-06-15
Summary:	summary