BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

BLACKSTONE MEDICAL, INC.

The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Blackstone Fusion Anterior Cervical Plating System.

Pre-market Notification Details

• Device ID: K030595
• 510k Number: K030595
• Device Name: BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield, MA 01104
• Contact: Dean E Ciporkin
• Correspondent: Dean E Ciporkin; BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield, MA 01104
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-02-25
• Decision Date: 2003-04-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18257200062461	K030595	000
18257200062607	K030595	000
18257200062614	K030595	000
18257200062621	K030595	000
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18257200062898	K030595	000
18257200062904	K030595	000
18257200062911	K030595	000
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18257200062850	K030595	000
18257200062737	K030595	000
18257200062744	K030595	000
18257200062751	K030595	000
18257200062768	K030595	000
18257200062775	K030595	000
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18257200062799	K030595	000
18257200062805	K030595	000
18257200062812	K030595	000
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18257200085224	K030595	000