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FDA 510(k)

U1 HIP SYSTEM

K-Number: K994078 · 2000-12-04

ApplicantUnited Orthopedic Corp.
Decision Date2000-12-04
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

U1 HIP SYSTEM 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 2000-12-04 under 510(k) number K994078. 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 U1 HIP SYSTEM?

U1 HIP SYSTEM is a medical device that received FDA 510(k) clearance on 2000-12-04. The listed applicant is United Orthopedic Corp.. The 510(k) number is K994078.

When did U1 HIP SYSTEM receive FDA 510(k) clearance?

U1 HIP SYSTEM received FDA 510(k) clearance on 2000-12-04, under 510(k) number K994078.

Who is the listed applicant for U1 HIP SYSTEM?

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 U1 HIP SYSTEM?

The FDA product code for U1 HIP SYSTEM is LPH.

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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: 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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