AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System

Plate, Fixation, Bone

Advanced Orthopaedic Solutions, Inc.

The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Aos Fibonacci Lower Extremity Plating System – Aos Proximal Tibia Plating System.

Pre-market Notification Details

• Device ID: K202489
• 510k Number: K202489
• Device Name: AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System
• Classification: Plate, Fixation, Bone
• Applicant: Advanced Orthopaedic Solutions, Inc. 3203 Kashiwa Street Torrance, CA 90505
• Contact: Jolie Krance
• Correspondent: Jolie Krance; Advanced Orthopaedic Solutions 3203 Kashiwa Street Torrance, CA 90505
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-08-31
• Decision Date: 2020-10-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00848665032147	K202489	000
00848665038200	K202489	000
00848665038217	K202489	000
00848665038224	K202489	000
00848665038231	K202489	000
00848665038248	K202489	000
00848665038255	K202489	000
00848665038262	K202489	000
00848665038279	K202489	000
00848665038286	K202489	000
00848665038293	K202489	000
00848665038309	K202489	000
00848665038316	K202489	000
00848665038323	K202489	000
00848665038330	K202489	000
00848665034295	K202489	000
00848665039320	K202489	000
00848665039443	K202489	000
00848665032192	K202489	000
00848665032208	K202489	000
00848665032215	K202489	000
00848665032222	K202489	000
00848665032239	K202489	000
00848665032376	K202489	000
00848665039351	K202489	000
00848665039368	K202489	000
00848665039375	K202489	000
00848665039382	K202489	000
00848665039399	K202489	000
00848665039405	K202489	000
00848665039412	K202489	000
00848665039436	K202489	000
00848665038347	K202489	000
00848665038354	K202489	000
00848665038361	K202489	000
00848665035261	K202489	000
00848665035278	K202489	000
00848665035285	K202489	000
00848665035414	K202489	000
00848665035421	K202489	000
00848665035438	K202489	000
00848665035445	K202489	000
00848665037296	K202489	000
00848665037302	K202489	000
00848665035179	K202489	000
00848665035186	K202489	000
00848665035193	K202489	000
00848665035209	K202489	000
00848665035216	K202489	000
00848665035254	K202489	000
00848665035247	K202489	000
00848665035230	K202489	000
00848665038378	K202489	000
00848665038385	K202489	000
00848665038392	K202489	000
00848665038408	K202489	000
00848665038415	K202489	000
00848665038422	K202489	000
00848665038439	K202489	000
00848665038446	K202489	000
00848665038453	K202489	000
00848665038460	K202489	000
00848665038477	K202489	000
00848665038484	K202489	000
00848665038491	K202489	000
00848665038507	K202489	000
00848665035223	K202489	000