PRIMA Humeral System And SMR Glenosphere Ø42

Shoulder Prosthesis, Reverse Configuration

LimaCorporate S.p.A.

The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Prima Humeral System And Smr Glenosphere Ø42.

Pre-market Notification Details

• Device ID: K212800
• 510k Number: K212800
• Device Name: PRIMA Humeral System And SMR Glenosphere Ø42
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: LimaCorporate S.p.A. Via Nazionale 52 Villanova Di San Daniele Del Friuli, IT 33038
• Contact: Antonia Trevisan
• Correspondent: Lacey Harbour; Lima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, TX 76006
• Product Code: PHX
• Subsequent Product Code: HSD
• Subsequent Product Code: KWS
• Subsequent Product Code: KWT
• Subsequent Product Code: PAO
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-02
• Decision Date: 2022-02-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08033390216456	K212800	000
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