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
03701037316450	K213117	000
03701037316979	K213117	000
03701037316986	K213117	000
03701037316993	K213117	000
03701037317006	K213117	000
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03701037317020	K213117	000
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03701037317044	K213117	000
03701037317051	K213117	000
03701037317068	K213117	000
03701037317075	K213117	000
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03701037317105	K213117	000
03701037316962	K213117	000
03701037316955	K213117	000
03701037320457	K213117	000
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03701037320471	K213117	000
03701037320488	K213117	000
03701037320495	K213117	000
03701037320396	K213117	000
03701037315330	K213117	000
03701037315347	K213117	000
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03701037315415	K213117	000
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03701037315446	K213117	000
03701037316948	K213117	000
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03701037317129	K213117	000
03701037317136	K213117	000
03701037315132	K213117	000
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03701037315125	K213117	000
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03701037317143	K213117	000
03701037317150	K213117	000
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03701037315392	K213117	000
03701037315453	K213117	000