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)

MICRO-STRUCTURED SURFACE HIP PROSTHESIS

K-Number: K831708 · 1983-09-15

ApplicantOsteonics Corp.
Decision Date1983-09-15
Product Code
DecisionSubstantially Equivalent

Device Summary

MICRO-STRUCTURED SURFACE HIP PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1983-09-15 under 510(k) number K831708. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-STRUCTURED SURFACE HIP PROSTHESIS?

MICRO-STRUCTURED SURFACE HIP PROSTHESIS is a medical device that received FDA 510(k) clearance on 1983-09-15. The listed applicant is Osteonics Corp.. The 510(k) number is K831708.

When did MICRO-STRUCTURED SURFACE HIP PROSTHESIS receive FDA 510(k) clearance?

MICRO-STRUCTURED SURFACE HIP PROSTHESIS received FDA 510(k) clearance on 1983-09-15, under 510(k) number K831708.

Who is the listed applicant for MICRO-STRUCTURED SURFACE HIP PROSTHESIS?

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

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 Osteonics 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.

K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYK980070OSTEONICS HA-COATED DEVICESK984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYK982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMK984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVEK990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

View all 178 devices →

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.

↑