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FDA 510(k)

CS2 HIP SYSTEM

K-Number: K122512 · 2012-11-05

ApplicantConsensus Orthopedics, Inc.
Decision Date2012-11-05
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CS2 HIP SYSTEM 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 2012-11-05 under 510(k) number K122512. 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 CS2 HIP SYSTEM?

CS2 HIP SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-05. The listed applicant is Consensus Orthopedics, Inc.. The 510(k) number is K122512.

When did CS2 HIP SYSTEM receive FDA 510(k) clearance?

CS2 HIP SYSTEM received FDA 510(k) clearance on 2012-11-05, under 510(k) number K122512.

Who is the listed applicant for CS2 HIP SYSTEM?

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 CS2 HIP SYSTEM?

The FDA product code for CS2 HIP SYSTEM is LPH.

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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 INSERTK120595UNISYN PLUS HIP STEMK121935TAPERSET HIP SMALL STEMS

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Related Devices (Code: LPH)

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.

K261453G7® Acetabular SystemZimmer BiometK253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, 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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