ACUMED CANNULATED SCREW SYSTEM

Screw, Fixation, Bone

ACUMED LLC

The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Cannulated Screw System.

Pre-market Notification Details

• Device ID: K123890
• 510k Number: K123890
• Device Name: ACUMED CANNULATED SCREW SYSTEM
• Classification: Screw, Fixation, Bone
• Applicant: ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124
• Contact: Kara Budor
• Correspondent: Kara Budor; ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-18
• Decision Date: 2013-03-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10806378114632	K123890	000
10806378114816	K123890	000
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