FX V135 Shoulder Prosthesis

Shoulder Prosthesis, Reverse Configuration

FX Shoulder USA, Inc.

The following data is part of a premarket notification filed by Fx Shoulder Usa, Inc. with the FDA for Fx V135 Shoulder Prosthesis.

Pre-market Notification Details

• Device ID: K213117
• 510k Number: K213117
• Device Name: FX V135 Shoulder Prosthesis
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: FX Shoulder USA, Inc. 13465 Midway Road, Suite 101 Dallas, TX 75244
• Contact: Kathy Trier
• Correspondent: Kathy Trier; FX Shoulder USA, Inc. 13465 Midway Road, Suite 101 Dallas, TX 75244
• Product Code: PHX
• Subsequent Product Code: HSD
• Subsequent Product Code: KWT
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-27
• Decision Date: 2022-06-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03701037320396	K213117	000
03701037317020	K213117	000
03701037317037	K213117	000
03701037317044	K213117	000
03701037317051	K213117	000
03701037317068	K213117	000
03701037317075	K213117	000
03701037317082	K213117	000
03701037317099	K213117	000
03701037317105	K213117	000
03701037317112	K213117	000
03701037317129	K213117	000
03701037317136	K213117	000
03701037317013	K213117	000
03701037317006	K213117	000
03701037316993	K213117	000
03701037315330	K213117	000
03701037315347	K213117	000
03701037315354	K213117	000
03701037315415	K213117	000
03701037315422	K213117	000
03701037315439	K213117	000
03701037315446	K213117	000
03701037316948	K213117	000
03701037316955	K213117	000
03701037316962	K213117	000
03701037316979	K213117	000
03701037316986	K213117	000
03701037317143	K213117	000
03701037317150	K213117	000
03701037317167	K213117	000
03701037315156	K213117	000
03701037315163	K213117	000
03701037315170	K213117	000
03701037315187	K213117	000
03701037315194	K213117	000
03701037315200	K213117	000
03701037315217	K213117	000
03701037315224	K213117	000
03701037315231	K213117	000
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03701037315255	K213117	000
03701037315262	K213117	000
03701037315149	K213117	000
03701037315132	K213117	000
03701037315125	K213117	000
03701037317174	K213117	000
03701037315279	K213117	000
03701037315286	K213117	000
03701037315293	K213117	000
03701037315309	K213117	000
03701037315316	K213117	000
03701037315323	K213117	000
03701037315361	K213117	000
03701037315378	K213117	000
03701037315385	K213117	000
03701037315392	K213117	000
03701037315408	K213117	000
03701037315453	K213117	000