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Platelet And Plasma Separator For Bone Graft Handling

Intra-Lock International

The following data is part of a premarket notification filed by Intra-lock International with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

• Device ID: BK120048
• 510k Number: BK120048
• Device Name: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
• Classification: Platelet And Plasma Separator For Bone Graft Handling
• Applicant: Intra-Lock International 6560 West Rogers Circle Boca Raton, FL 33487
• Product Code: ORG
• CFR Regulation Number: 864.9245 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-08-17
• Decision Date: 2013-01-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D742BTUBEHOLD1	BK120048	0
00847236015855	BK120048	0
00847236015848	BK120048	0
00847236015831	BK120048	0
00847236015978	BK120048	0
00847236015961	BK120048	0
00847236015954	BK120048	0
00847236015947	BK120048	0
00847236015930	BK120048	0
00847236015923	BK120048	0
00847236015916	BK120048	0
00847236015909	BK120048	0
00847236016043	BK120048	0
00847236015862	BK120048	0
00847236015879	BK120048	0
D742BROTOR1	BK120048	0
D742BPOWER2201	BK120048	0
D742BPOWER1101	BK120048	0
D742BHEX1	BK120048	0
D742BFUSE2201	BK120048	0
D742BFUSE1101	BK120048	0
D742WCT50	BK120048	0
D742BVBCTP250	BK120048	0
00847236015824	BK120048	0
00847236015817	BK120048	0
00847236015893	BK120048	0
00847236015886	BK120048	0
00847236016036	BK120048	0