FDA 510(k)

STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX

K-Number: K021346 · 2002-07-02

Decision Date2002-07-02

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2002-07-02 under 510(k) number K021346. 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 STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX?

STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX is a medical device that received FDA 510(k) clearance on 2002-07-02. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K021346.

When did STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX receive FDA 510(k) clearance?

STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX received FDA 510(k) clearance on 2002-07-02, under 510(k) number K021346.

Who is the listed applicant for STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX?

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

What is the FDA product code for STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX?

The FDA product code for STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX is LPH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Wrightmedicaltechnologyinc as applicant

K222835Prophecy Preoperative Navigation Alignment System K213342PRO-DENSE LoVisc Bone Graft Substitute K212996Sterile PHALINX Hammertoe System K202815PROPHECY Preoperative Navigation Alignment System K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System K200507PRO-DENSE LoVisc Bone Graft Substitute

View all 268 devices →

Related Devices (Code: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 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 Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® 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.