Entrada™ Hip Stem

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

Ortho Development Corporation

The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for Entrada™ Hip Stem.

Pre-market Notification Details

• Device ID: K171249
• 510k Number: K171249
• Device Name: Entrada™ Hip Stem
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• Applicant: Ortho Development Corporation 12187 South Business Park Drive Draper, UT 84020
• Contact: Drew Weaver
• Correspondent: Drew Weaver; Ortho Development Corporation 12187 South Business Park Drive Draper, UT 84020
• Product Code: MEH
• Subsequent Product Code: KWL
• Subsequent Product Code: KWY
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-28
• Decision Date: 2017-08-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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