CURIOS

Filler, Bone Void, Calcium Compound

PROGENTIX ORTHOBIOLOGY B.V.

The following data is part of a premarket notification filed by Progentix Orthobiology B.v. with the FDA for Curios.

Pre-market Notification Details

• Device ID: K090641
• 510k Number: K090641
• Device Name: CURIOS
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: PROGENTIX ORTHOBIOLOGY B.V. PROF. BRONKHORSTLAAN 10 BLDG. 48 Bilthoven, NL 3723mb
• Contact: Yvonne P Bovell
• Correspondent: Yvonne P Bovell; PROGENTIX ORTHOBIOLOGY B.V. PROF. BRONKHORSTLAAN 10 BLDG. 48 Bilthoven, NL 3723mb
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-03-10
• Decision Date: 2009-10-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887517940025	K090641	000
00887517241535	K090641	000
00887517241542	K090641	000
00887517241559	K090641	000
00887517241566	K090641	000
00887517939951	K090641	000
00887517939968	K090641	000
00887517939975	K090641	000
00887517939982	K090641	000
00887517939999	K090641	000
00887517940001	K090641	000
00887517940018	K090641	000
00887517241528	K090641	000