HAMMERLOCK

Pin, Fixation, Smooth

BIOMEDICAL ENT., INC.

The following data is part of a premarket notification filed by Biomedical Ent., Inc. with the FDA for Hammerlock.

Pre-market Notification Details

• Device ID: K091951
• 510k Number: K091951
• Device Name: HAMMERLOCK
• Classification: Pin, Fixation, Smooth
• Applicant: BIOMEDICAL ENT., INC. 14785 OMICRON DR., SUITE 205 San Antonio, TX 78245
• Contact: Joe W Soward
• Correspondent: Joe W Soward; BIOMEDICAL ENT., INC. 14785 OMICRON DR., SUITE 205 San Antonio, TX 78245
• Product Code: HTY
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-07-01
• Decision Date: 2010-02-19
• Summary: summary