MBCP

Filler, Bone Void, Calcium Compound

BIOMATLANTE

The following data is part of a premarket notification filed by Biomatlante with the FDA for Mbcp.

Pre-market Notification Details

• Device ID: K051774
• 510k Number: K051774
• Device Name: MBCP
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: BIOMATLANTE 5, RUE EDOUARD BELIN Vigneux De Bretagne, FR 44360
• Contact: Myriam Vincent
• Correspondent: Myriam Vincent; BIOMATLANTE 5, RUE EDOUARD BELIN Vigneux De Bretagne, FR 44360
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2005-07-01
• Decision Date: 2006-01-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700501813273	K051774	000
03700501813075	K051774	000
03700501813068	K051774	000
03700501813037	K051774	000
03700501813020	K051774	000
03700501813013	K051774	000
03700501813006	K051774	000
03700501812993	K051774	000
03700501812986	K051774	000
03700501812979	K051774	000
03700501813082	K051774	000
03700501813099	K051774	000
03700501813105	K051774	000
03700501813266	K051774	000
03700501813259	K051774	000
03700501813242	K051774	000
03700501813235	K051774	000
03700501813228	K051774	000
03700501813211	K051774	000
03700501813136	K051774	000
03700501813129	K051774	000
03700501813112	K051774	000
03700501812962	K051774	000
03700501812955	K051774	000
03700501806732	K051774	000
03700501806725	K051774	000
03700501806718	K051774	000
03700501806701	K051774	000
03700501806695	K051774	000
03700501806688	K051774	000
03700501806671	K051774	000
03700501806664	K051774	000
03700501806657	K051774	000
03700501806749	K051774	000
03700501806756	K051774	000
03700501812825	K051774	000
03700501812948	K051774	000
03700501812931	K051774	000
03700501812924	K051774	000
03700501812917	K051774	000
03700501812900	K051774	000
03700501812894	K051774	000
03700501812856	K051774	000
03700501812849	K051774	000
03700501812832	K051774	000
03700501814133	K051774	000
00370050186091	K051774	000
H132000060130001	K051774	000
H131001109114011	K051774	000
H131001109113021	K051774	000
03700501806640	K051774	000
03700501803137	K051774	000
03700501803120	K051774	000
03700501803113	K051774	000
03700501800662	K051774	000
03700501800259	K051774	000
H132001109000361	K051774	000
H132001109000481	K051774	000
H132001109005031	K051774	000
H132001109132151	K051774	000
H132001109115021	K051774	000
H132001109115011	K051774	000
H132001109114021	K051774	000
H132001109113011	K051774	000
H132001109085151	K051774	000
H132001109006121	K051774	000
H132001109005251	K051774	000
H132001109005101	K051774	000
03700501800242	K051774	000
03700501800235	K051774	000
03700501800105	K051774	000
03700501800099	K051774	000
03700501800082	K051774	000
03700501800068	K051774	000
03700501800051	K051774	000
03700501800044	K051774	000
03700501800037	K051774	000
03700501800020	K051774	000
03700501800013	K051774	000
03700501800112	K051774	000
03700501800129	K051774	000
03700501800136	K051774	000
03700501800228	K051774	000
03700501800211	K051774	000
03700501800204	K051774	000
03700501800198	K051774	000
03700501800181	K051774	000
03700501800174	K051774	000
03700501800167	K051774	000
03700501800150	K051774	000
03700501800143	K051774	000
03700501813280	K051774	000