FDA 510(k)

26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER

K-Number: K991622 · 1999-07-14

Decision Date1999-07-14

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

26 MM CAST COCR HEAD AND POLYETHYLENE 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 1999-07-14 under 510(k) number K991622. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER?

26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER is a medical device that received FDA 510(k) clearance on 1999-07-14. The listed applicant is Stelkast Company. The 510(k) number is K991622.

When did 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER receive FDA 510(k) clearance?

26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER received FDA 510(k) clearance on 1999-07-14, under 510(k) number K991622.

Who is the listed applicant for 26 MM CAST COCR HEAD AND POLYETHYLENE 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 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER?

The FDA product code for 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER is JDI.

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 Stelkast Company as applicant

K122883EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM K122773CROSS-OVER ACETABULAR SHELL & LINER K094035EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM K081458PROVEN STEM EXTENDER K063211PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT K051976PROVEN REVISION MODULAR TIBIAL TRAY

View all 40 devices →

Related Devices (Code: JDI)

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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.