FDA 510(k)

UCP Stem

K-Number: K152530 · 2016-03-14

Decision Date2016-03-14

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

UCP Stem is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2016-03-14 under approval number K152530. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UCP Stem?

UCP Stem is a medical device that received FDA 510(k) clearance on 2016-03-14. It is manufactured by United Orthopedic Corporation. The 510(k) number is K152530.

When was UCP Stem approved by the FDA?

UCP Stem received FDA 510(k) clearance on 2016-03-14, under approval number K152530.

What company makes UCP Stem?

UCP Stem is manufactured by United Orthopedic Corporation.

What is the FDA product code for UCP Stem?

The FDA product code for UCP Stem is LZO.

Other Devices by United Orthopedic Corporation

K152430All Poly Tibial Component K152439U2 Bipolar Implant and 22mm Femoral Head K172251UTS Stem K170089U-Motion II Acetabular System Additional sizes K163441Locking Cage, Full XPE Cup K162957U2 Femoral Head

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Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

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.