Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INTERSEAL ACETABULAR SCREW HOLE PLUG

K-Number: K971429 · 1997-07-09

ApplicantWrightmedicaltechnologyinc
Decision Date1997-07-09
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTERSEAL ACETABULAR SCREW HOLE PLUG is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 1997-07-09 under 510(k) number K971429. 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 INTERSEAL ACETABULAR SCREW HOLE PLUG?

INTERSEAL ACETABULAR SCREW HOLE PLUG is a medical device that received FDA 510(k) clearance on 1997-07-09. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K971429.

When did INTERSEAL ACETABULAR SCREW HOLE PLUG receive FDA 510(k) clearance?

INTERSEAL ACETABULAR SCREW HOLE PLUG received FDA 510(k) clearance on 1997-07-09, under 510(k) number K971429.

Who is the listed applicant for INTERSEAL ACETABULAR SCREW HOLE PLUG?

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 INTERSEAL ACETABULAR SCREW HOLE PLUG?

The FDA product code for INTERSEAL ACETABULAR SCREW HOLE PLUG 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Wrightmedicaltechnologyinc 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.

K222835Prophecy Preoperative Navigation Alignment SystemK213342PRO-DENSE LoVisc Bone Graft SubstituteK212996Sterile PHALINX Hammertoe SystemK202815PROPHECY Preoperative Navigation Alignment SystemK201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemK200507PRO-DENSE LoVisc Bone Graft Substitute

View all 268 devices →

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.

↑