APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM

Screw, Fixation, Bone

CAYENNE MEDICAL, INC.

The following data is part of a premarket notification filed by Cayenne Medical, Inc. with the FDA for Aperfix Implant With Inserter, 8, 9, 10, 11, Mm X30 Mm.

Pre-market Notification Details

• Device ID: K083607
• 510k Number: K083607
• Device Name: APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM
• Classification: Screw, Fixation, Bone
• Applicant: CAYENNE MEDICAL, INC. 16597 N. 92ND STREET SUITE 101 Scottsdale, AZ 85260
• Contact: Kereshmeh Shahriari
• Correspondent: Kereshmeh Shahriari; CAYENNE MEDICAL, INC. 16597 N. 92ND STREET SUITE 101 Scottsdale, AZ 85260
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-05
• Decision Date: 2009-03-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868269714	K083607	000
00887868269707	K083607	000
00887868269691	K083607	000
00887868269684	K083607	000