UTS Stem

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

United Orthopedic Corporation

The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for Uts Stem.

Pre-market Notification Details

• Device ID: K172251
• 510k Number: K172251
• Device Name: UTS Stem
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: United Orthopedic Corporation No 57, Park Ave 2, Science Park Hsinchu, TW 300
• Contact: Gimpel Chien
• Correspondent: Gimpel Chien; United Orthopedic Corporation No 57, Park Ave 2, Science Park Hsinchu, TW 300
• Product Code: LPH
• Subsequent Product Code: KWY
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-26
• Decision Date: 2017-10-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04719886900439	K172251	000
04711605582155	K172251	000
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04719872156260	K172251	000
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04719872156475	K172251	000