MagnetOs

Filler, Bone Void, Calcium Compound

XPAND BIOTECHNOLOGY BV

The following data is part of a premarket notification filed by Xpand Biotechnology Bv with the FDA for Magnetos.

Pre-market Notification Details

• Device ID: K161859
• 510k Number: K161859
• Device Name: MagnetOs
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: XPAND BIOTECHNOLOGY BV PROFESSOR BRONKHORSTLAAN 10D, BUILDING 48 Bilthoven, NL 3723 Mb
• Contact: Yvonne P. Bovell
• Correspondent: Yvonne P. Bovell; XPAND BIOTECHNOLOGY BV PROFESSOR BRONKHORSTLAAN 10D, BUILDING 48 Bilthoven, NL 3723 Mb
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-07-06
• Decision Date: 2017-02-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08719699710269	K161859	000
08719699710115	K161859	000
08719699710108	K161859	000
08719699710092	K161859	000
08719699710085	K161859	000
08719699710078	K161859	000
08719699710061	K161859	000
08719699710054	K161859	000
08719699710047	K161859	000
08719699710030	K161859	000
08719699710023	K161859	000
08719699710139	K161859	000
08719699710146	K161859	000
08719699710153	K161859	000
08719699710252	K161859	000
08719699710245	K161859	000
08719699710238	K161859	000
08719699710221	K161859	000
08719699710214	K161859	000
08719699710207	K161859	000
08719699710191	K161859	000
08719699710184	K161859	000
08719699710177	K161859	000
08719699710160	K161859	000
08719699710009	K161859	000