FDA 510(k)

UTS Stem

K-Number: K172251 · 2017-10-24

Decision Date2017-10-24

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

UTS Stem is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2017-10-24 under approval number K172251. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UTS Stem?

UTS Stem is a medical device that received FDA 510(k) clearance on 2017-10-24. It is manufactured by United Orthopedic Corporation. The 510(k) number is K172251.

When was UTS Stem approved by the FDA?

UTS Stem received FDA 510(k) clearance on 2017-10-24, under approval number K172251.

What company makes UTS Stem?

UTS Stem is manufactured by United Orthopedic Corporation.

What is the FDA product code for UTS Stem?

The FDA product code for UTS Stem is LPH.

Other Devices by United Orthopedic Corporation

K152430All Poly Tibial Component K152439U2 Bipolar Implant and 22mm Femoral Head K152530UCP Stem K170089U-Motion II Acetabular System Additional sizes K163441Locking Cage, Full XPE Cup K162957U2 Femoral Head

View all 26 devices →

Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.