SIGNATURE PLANNER, SIGNATURE GUIDES

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

MATERIALISE N.V.

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

Pre-market Notification Details

• Device ID: K140257
• 510k Number: K140257
• Device Name: SIGNATURE PLANNER, SIGNATURE GUIDES
• Classification: Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
• Applicant: MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001
• Contact: Oliver Clemens
• Correspondent: Oliver Clemens; MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001
• Product Code: MBH
• Subsequent Product Code: JWH
• Subsequent Product Code: MBV
• Subsequent Product Code: OIY
• Subsequent Product Code: OOG
• CFR Regulation Number: 888.3565 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-02-03
• Decision Date: 2014-04-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304999541	K140257	000
00880304616783	K140257	000
E314SIGNATURE0	K140257	000
E314424334100	K140257	000
E31442433410	K140257	000
00887868498794	K140257	000
00887868501210	K140257	000