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)

RESOLUTION(TM) HIP STEM

K-Number: K933570 · 1994-03-07

ApplicantWrightmedicaltechnologyinc
Decision Date1994-03-07
Product CodeLJW
Advisory CommitteeEN
DecisionSubstantially Equivalent for Some Indications

Device Summary

RESOLUTION(TM) HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 1994-03-07 under 510(k) number K933570. The device is classified under product code LJW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the RESOLUTION(TM) HIP STEM?

RESOLUTION(TM) HIP STEM is a medical device that received FDA 510(k) clearance on 1994-03-07. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K933570.

When did RESOLUTION(TM) HIP STEM receive FDA 510(k) clearance?

RESOLUTION(TM) HIP STEM received FDA 510(k) clearance on 1994-03-07, under 510(k) number K933570.

Who is the listed applicant for RESOLUTION(TM) HIP STEM?

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 RESOLUTION(TM) HIP STEM?

The FDA product code for RESOLUTION(TM) HIP STEM is LJW.

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: LJW)

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.

K822618EMERGENCY TRACHEOSTOMY INSTRUMENT SETKelleher Corp.

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.

↑