Acumed Ankle And Small Fragment Base Set Update

Plate, Fixation, Bone

Acumed, LLC

The following data is part of a premarket notification filed by Acumed, Llc with the FDA for Acumed Ankle And Small Fragment Base Set Update.

Pre-market Notification Details

• Device ID: K151886
• 510k Number: K151886
• Device Name: Acumed Ankle And Small Fragment Base Set Update
• Classification: Plate, Fixation, Bone
• Applicant: Acumed, LLC 5885 NW Cornelius Pass Road Hillsboro, OR 97124
• Contact: Kara Budor
• Correspondent: Nathan Wolf; Wolf Regulatory Consulting LLC PO Box 796 Loma Linda, CA 92354
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-07-09
• Decision Date: 2015-10-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10806378100192	K151886	000
10806378100338	K151886	000
10806378100345	K151886	000
10806378100352	K151886	000
10806378100369	K151886	000
10806378100383	K151886	000
10806378100390	K151886	000
10806378100406	K151886	000
10806378100413	K151886	000
10806378100420	K151886	000
10806378100437	K151886	000
10806378100321	K151886	000
10806378100314	K151886	000
10806378100307	K151886	000
10806378100208	K151886	000
10806378100215	K151886	000
10806378100222	K151886	000
10806378100239	K151886	000
10806378100246	K151886	000
10806378100253	K151886	000
10806378100260	K151886	000
10806378100277	K151886	000
10806378100284	K151886	000
10806378100291	K151886	000
10806378101274	K151886	000
10806378101281	K151886	000
10806378101298	K151886	000
10806378101434	K151886	000
10806378101441	K151886	000
10806378101465	K151886	000
10806378101472	K151886	000
10806378101489	K151886	000
10806378101496	K151886	000
10806378101502	K151886	000
10806378105142	K151886	000
10806378105159	K151886	000
10806378105166	K151886	000
10806378101427	K151886	000
10806378101410	K151886	000
10806378101403	K151886	000
10806378101304	K151886	000
10806378101311	K151886	000
10806378101328	K151886	000
10806378101335	K151886	000
10806378101342	K151886	000
10806378101359	K151886	000
10806378101366	K151886	000
10806378101373	K151886	000
10806378101380	K151886	000
10806378101397	K151886	000
10806378105173	K151886	000