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FDA 510(k)

U2 HIP STEM, TI PLASMA SPRAY

K-Number: K062978 · 2007-01-16

ApplicantUnited Orthopedic Corp.
Decision Date2007-01-16
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

U2 HIP STEM, TI PLASMA SPRAY is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corp.. It received FDA 510(k) clearance on 2007-01-16 under 510(k) number K062978. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U2 HIP STEM, TI PLASMA SPRAY?

U2 HIP STEM, TI PLASMA SPRAY is a medical device that received FDA 510(k) clearance on 2007-01-16. The listed applicant is United Orthopedic Corp.. The 510(k) number is K062978.

When did U2 HIP STEM, TI PLASMA SPRAY receive FDA 510(k) clearance?

U2 HIP STEM, TI PLASMA SPRAY received FDA 510(k) clearance on 2007-01-16, under 510(k) number K062978.

Who is the listed applicant for U2 HIP STEM, TI PLASMA SPRAY?

The FDA 510(k) record lists United Orthopedic Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U2 HIP STEM, TI PLASMA SPRAY?

The FDA product code for U2 HIP STEM, TI PLASMA SPRAY is LWJ.

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Other records listing United Orthopedic Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132455U-MOTION II PS+ CUPK122185U-MOTION II ACETABULAR SYSTEMK122183AUGMENT AND SCREW, PSA TYPEK121777U2 ACETABULAR CUP, PLASMA SPRAYK111546U2 HIP SYSTEMK103497CERAMIC FEMORAL HEAD

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Related Devices (Code: LWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062383UNISYN HA PLASMA MODULAR HIPHayes Medical, 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.

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