FDA 510(k), K182468, Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
FDA 510(k), K182468, Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
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510(K) Number: K182468
Device Name: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
Manufacturer: Howmedica Osteonics Corp aka Stryker Orthopaedics
Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Regulation Number: 888.3358
Classification Product Code: LPH
Date Received: 09/10/2018
Decision Date: 03/19/2019
Regulation Medical Specialty: Orthopedic
Device Name: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
Manufacturer: Howmedica Osteonics Corp aka Stryker Orthopaedics
Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Regulation Number: 888.3358
Classification Product Code: LPH
Date Received: 09/10/2018
Decision Date: 03/19/2019
Regulation Medical Specialty: Orthopedic
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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