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FDA 510(k)

UNISYN PLUS HIP STEM

K-Number: K120595 · 2012-10-12

ApplicantConsensus Orthopedics, Inc.
Decision Date2012-10-12
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNISYN PLUS HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Consensus Orthopedics, Inc.. It received FDA 510(k) clearance on 2012-10-12 under 510(k) number K120595. 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 UNISYN PLUS HIP STEM?

UNISYN PLUS HIP STEM is a medical device that received FDA 510(k) clearance on 2012-10-12. The listed applicant is Consensus Orthopedics, Inc.. The 510(k) number is K120595.

When did UNISYN PLUS HIP STEM receive FDA 510(k) clearance?

UNISYN PLUS HIP STEM received FDA 510(k) clearance on 2012-10-12, under 510(k) number K120595.

Who is the listed applicant for UNISYN PLUS HIP STEM?

The FDA 510(k) record lists Consensus Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNISYN PLUS HIP STEM?

The FDA product code for UNISYN PLUS HIP STEM is LWJ.

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Other records listing Consensus Orthopedics, Inc. as applicant

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K170344Tahoe Uni Knee SystemK163167CKS Plus Knee SystemK160515PS2 Knee SystemK130652VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERTK122512CS2 HIP SYSTEMK121935TAPERSET HIP SMALL STEMS

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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.

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.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.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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