RETROGRADE FEMORAL NAIL

Rod, Fixation, Intramedullary And Accessories

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Retrograde Femoral Nail.

Pre-market Notification Details

• Device ID: K132005
• 510k Number: K132005
• Device Name: RETROGRADE FEMORAL NAIL
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 Beech Ave. Unit B6 Torrance, CA 90501
• Contact: Allyson Parks
• Correspondent: Allyson Parks; ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 Beech Ave. Unit B6 Torrance, CA 90501
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-07-01
• Decision Date: 2013-09-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00848665007169	K132005	000
00848665012682	K132005	000
00848665012699	K132005	000
00848665012705	K132005	000
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00848665012835	K132005	000
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