BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)

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 Iii Degree Anterior Cervical Plating System (plate Washer).

Pre-market Notification Details

• Device ID: K020620
• 510k Number: K020620
• Device Name: BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield, MA 01104
• Contact: Alan Lombardo
• Correspondent: Alan Lombardo; 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: 2002-02-25
• Decision Date: 2002-05-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18257200059065	K020620	000
18257200059232	K020620	000
18257200059249	K020620	000
18257200059256	K020620	000
18257200059263	K020620	000
18257200059270	K020620	000
18257200059287	K020620	000
18257200059294	K020620	000
18257200059300	K020620	000
18257200059317	K020620	000
18257200059324	K020620	000
18257200059331	K020620	000
18257200059348	K020620	000
18257200059355	K020620	000
18257200059225	K020620	000
18257200059218	K020620	000
18257200059201	K020620	000
18257200059072	K020620	000
18257200059089	K020620	000
18257200059096	K020620	000
18257200059102	K020620	000
18257200059119	K020620	000
18257200059126	K020620	000
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18257200059140	K020620	000
18257200059157	K020620	000
18257200059164	K020620	000
18257200059171	K020620	000
18257200059188	K020620	000
18257200059195	K020620	000
18257200059362	K020620	000
18257200059379	K020620	000
18257200059386	K020620	000
18257200059553	K020620	000
18257200059560	K020620	000
18257200059577	K020620	000
18257200059584	K020620	000
18257200059591	K020620	000
18257200059607	K020620	000
18257200059614	K020620	000
18257200059621	K020620	000
18257200059638	K020620	000
18257200059645	K020620	000
18257200059652	K020620	000
18257200059669	K020620	000
18257200059676	K020620	000
18257200059546	K020620	000
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18257200059492	K020620	000
18257200059508	K020620	000
18257200059515	K020620	000
18257200081509	K020620	000