AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

Encore Medical, L.P.

The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Altivate Reverse Humeral Stem, Altivate Reverse Small Spacer, Altivate Reverse, Small Hemi-adapter, Altivate Reverse, Small Socket Insert.

Pre-market Notification Details

• Device ID: K172351
• 510k Number: K172351
• Device Name: AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
• Contact: Teffany Hutto
• Correspondent: Teffany Hutto; Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
• Product Code: KWS
• Subsequent Product Code: HSD
• Subsequent Product Code: PHX
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-03
• Decision Date: 2017-10-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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