ATHENA PEDICLE SCREW SYSTEM

Thoracolumbosacral Pedicle Screw System

ROYAL OAK MEDICAL DEVICES

The following data is part of a premarket notification filed by Royal Oak Medical Devices with the FDA for Athena Pedicle Screw System.

Pre-market Notification Details

• Device ID: K110046
• 510k Number: K110046
• Device Name: ATHENA PEDICLE SCREW SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: ROYAL OAK MEDICAL DEVICES 39533 WOODWARD AVENUE Bloomfield Hills, MI 48304
• Contact: Mathew Kroll
• Correspondent: Mathew Kroll; ROYAL OAK MEDICAL DEVICES 39533 WOODWARD AVENUE Bloomfield Hills, MI 48304
• Product Code: NKB
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-01-06
• Decision Date: 2011-12-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M696SP200140	K110046	000
00812352020113	K110046	000
00812352020120	K110046	000
00812352020137	K110046	000
00812352020144	K110046	000
00812352020151	K110046	000
00812352020168	K110046	000
00812352020175	K110046	000
00812352020182	K110046	000
00812352020199	K110046	000
00812352020205	K110046	000
00812352020212	K110046	000
00812352020229	K110046	000
00812352020236	K110046	000
00812352020243	K110046	000
00812352020106	K110046	000
00812352020090	K110046	000
M696SP200150	K110046	000
M696SP200160	K110046	000
M69622011200	K110046	000
M69622111200	K110046	000
M69622310200	K110046	000
M6962261010L0	K110046	000
M6962261020R0	K110046	000
M69633710200	K110046	000
M69623010410	K110046	000
M69623020410	K110046	000
00812352020007	K110046	000
00812352020014	K110046	000
00812352020076	K110046	000
00812352020083	K110046	000
00812352020250	K110046	000
00812352020267	K110046	000
00812352020274	K110046	000
00812352020441	K110046	000
00812352020458	K110046	000
00812352020465	K110046	000
00812352020472	K110046	000
00812352020489	K110046	000
00812352020496	K110046	000
00812352020502	K110046	000
00812352020519	K110046	000
00812352020526	K110046	000
00812352020533	K110046	000
00812352020540	K110046	000
00812352020557	K110046	000
00812352020564	K110046	000
00812352021301	K110046	000
00812352020434	K110046	000
00812352020427	K110046	000
00812352020281	K110046	000
00812352020298	K110046	000
00812352020304	K110046	000
00812352020311	K110046	000
00812352020328	K110046	000
00812352020335	K110046	000
00812352020342	K110046	000
00812352020359	K110046	000
00812352020366	K110046	000
00812352020373	K110046	000
00812352020380	K110046	000
00812352020397	K110046	000
00812352020403	K110046	000
00812352020410	K110046	000
00812352021318	K110046	000