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)

CROSS-OVER ACETABULAR SHELL & LINER

K-Number: K122773 · 2012-10-09

ApplicantStelkast Company
Decision Date2012-10-09
Product CodeOQG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CROSS-OVER ACETABULAR SHELL & LINER is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 2012-10-09 under 510(k) number K122773. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CROSS-OVER ACETABULAR SHELL & LINER?

CROSS-OVER ACETABULAR SHELL & LINER is a medical device that received FDA 510(k) clearance on 2012-10-09. The listed applicant is Stelkast Company. The 510(k) number is K122773.

When did CROSS-OVER ACETABULAR SHELL & LINER receive FDA 510(k) clearance?

CROSS-OVER ACETABULAR SHELL & LINER received FDA 510(k) clearance on 2012-10-09, under 510(k) number K122773.

Who is the listed applicant for CROSS-OVER ACETABULAR SHELL & LINER?

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

What is the FDA product code for CROSS-OVER ACETABULAR SHELL & LINER?

The FDA product code for CROSS-OVER ACETABULAR SHELL & LINER is OQG.

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 Stelkast Company 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.

K122883EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEMK094035EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MMK081458PROVEN STEM EXTENDERK063211PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERTK051976PROVEN REVISION MODULAR TIBIAL TRAYK033944STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD

View all 40 devices →

Related Devices (Code: OQG)

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.

K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.K172651FMP Extended LinersEncore Medical L.P.K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies

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.

↑